Data / Medical devices / United States / Ge Medical Systems, LLC
Ge Medical Systems, LLC: FDA-registered device maker in Waukesha, WI, United States, 65 510(k) clearances
Ge Medical Systems, LLC is registered with the FDA (registration 2126677) in Waukesha, WI, United States. It lists 17 device types. The FDA files 65 510(k) clearances under its listings, the newest dated June 24, 2026. 426 recall events name it as the recalling firm (19 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2126677
- Address
- 3000 N Grandview BLVD., Waukesha, WI, United States, 53188
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- AMX Navigate, AMX Navigate UPGRADE, AS, ASiR-V, Auto Positioning, Auto Segmentation, Autolaunch, Brivo XR285amx and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2026 | K253560 | Enhanced Boundary for PCCT | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 14, 2026 | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | QIH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 23, 2026 | K253686 | True Definition DL | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| March 20, 2026 | K253520 | Photonova Spectra, Photonova Spectra Select | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 1, 2025 | K250941 | Revolution Vibe | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 8, 2024 | K241665 | Omni Legend | KPS | Substantially Equivalent | Ge Medical Systems Israel, Functional Imaging | accessdata.fda.gov |
| April 11, 2024 | K233698 | True Enhance DL | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| April 2, 2024 | K233750 | ECG-less Cardiac | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 25, 2023 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | QBS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 4, 2023 | K230082 | Auto Segmentation | QKB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 27, 2023 | K223212 | Precision DL | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 20, 2023 | K230807 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| March 9, 2023 | K223514 | Spectral Bone Marrow | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 2, 2022 | K221932 | Omni Legend | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 18, 2022 | K213999 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 4, 2022 | K213938 | Revolution Ascend | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| December 17, 2021 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 29, 2021 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | QIH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 20, 2021 | K211846 | Discovery MI Gen2 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 28, 2021 | K210982 | AMX Navigate | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 2, 2021 | K203617 | MaxFOV 2 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 10, 2020 | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 16, 2020 | K192956 | Auto Positioning | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| October 24, 2019 | K192686 | Revolution Maxima, Revolution Ace | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| August 12, 2019 | K183182 | Critical Care Suite | QFM | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 26, 2019 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 12, 2019 | K183202 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 13, 2019 | K183161 | SnapShot Freeze 2 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 6, 2018 | K182234 | Optima XR240amx | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 11, 2018 | K180318 | PET Digital Gating | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 12, 2018 | K173602 | Optima XR240amx, AutoGrid | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 16, 2016 | K163213 | Revolution CT | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 15, 2016 | K162990 | Optima XR240amx | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 11, 2016 | K161574 | Discovery MI | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 9, 2016 | K153429 | SmartView 3D Option | JAK | Substantially Equivalent | Ge Hangwei Medical System Co., Ltd. | accessdata.fda.gov |
| August 14, 2015 | K151372 | Low Dose CT Lung Cancer Screening Option for Qualified GE Systems | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 24, 2015 | K150193 | Customer Remote Console (CRC) | LLZ | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 25, 2014 | K142383 | Optima XR200amx, Optima XR220amx | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 18, 2014 | K141477 | DISCOVERY IQ | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 18, 2014 | K141074 | CORTEX ID SUITE | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 11, 2014 | K133705 | REVOLUTION CT | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 25, 2014 | K133640 | ASIR-V | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 17, 2014 | K132410 | DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 13, 2012 | K121827 | GSI VIEWER WITH VUE OPTION | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| June 12, 2012 | K120833 | DISCOVERY CT750 HD | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 9, 2011 | K103489 | GE VEO RECONSTRUCTION OPTION | JAK | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| July 20, 2011 | K110227 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 16, 2011 | K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 19, 2011 | K093581 | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 17, 2008 | K082960 | GE XTREME INJECTOR OPTION | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 11, 2008 | K081091 | PRECISION 500D R&F X-RAY SYSTEM | JAA | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 9, 2008 | K081105 | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 17, 2006 | K063283 | DEFINIUM 5000 X-RAY SYSTEM | MQB | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| July 12, 2006 | K061817 | LIGHTSPEED 7.1 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 9, 2005 | K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS | KPR | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 17, 2005 | K050559 | GE DISCOVERY VCT SYSTEM | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 22, 2004 | K041521 | VOLUME VIEWER PLUS | JAK | Substantially Equivalent | General Electric Medical Systems | accessdata.fda.gov |
| March 1, 2004 | K040372 | LIGHTSPEED 7.0 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 8, 2001 | K011624 | EXPEDIO 500D R&F X-RAY SYSTEM | JAA | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| September 23, 1994 | K943805 | PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD | JAA | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 426.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 5, 2026 | 99279 | Class II | Ongoing | Optima XR200amx, Mobile Digital-Ready Radiographic System | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collim | accessdata.fda.gov |
| May 1, 2026 | 98986 | Class II | Ongoing | Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple f | accessdata.fda.gov |
| April 20, 2026 | 98880 | Class II | Ongoing | Allia IGS 3 Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON. | accessdata.fda.gov |
| March 26, 2026 | 98738 | Class II | Ongoing | Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. | accessdata.fda.gov |
| February 3, 2026 | 98447 | Class II | Ongoing | Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP | There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. | accessdata.fda.gov |
| January 30, 2026 | 98428 | Class II | Ongoing | Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-0 | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. | accessdata.fda.gov |
| October 24, 2025 | 98081 | Class II | Ongoing | Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j). | accessdata.fda.gov |
| September 18, 2025 | 97726 | Class II | Ongoing | LOGIQ P10 series with software version R4.5.7 Model Number 5877534 | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. | accessdata.fda.gov |
| August 22, 2025 | 97564 | Class II | Ongoing | MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4 | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use. | accessdata.fda.gov |
| July 2, 2025 | 97454 | Class II | Ongoing | GE HealthCare OEC 9800. | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by th | accessdata.fda.gov |
| March 21, 2025 | 96902 | Class II | Ongoing | OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | accessdata.fda.gov |
| March 6, 2025 | 96538 | Class II | Ongoing | Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Numb | The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. | accessdata.fda.gov |
| February 18, 2025 | 96370 | Class II | Ongoing | GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful tempera | accessdata.fda.gov |
| January 28, 2025 | 96208 | Class II | Ongoing | Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system. | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached. | accessdata.fda.gov |
| December 6, 2024 | 96027 | Class II | Ongoing | Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure a | There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time. | accessdata.fda.gov |
| November 25, 2024 | 95958 | Class II | Ongoing | GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and c | accessdata.fda.gov |
| November 18, 2024 | 95855 | Class II | Ongoing | Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-00 | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. | accessdata.fda.gov |
| November 16, 2022 | 91176 | Class II | Ongoing | B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level. | accessdata.fda.gov |
| November 10, 2022 | 91139 | Class II | Ongoing | Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Periphe | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. | accessdata.fda.gov |
| October 28, 2022 | 91159 | Class II | Ongoing | Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources. | There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study. | accessdata.fda.gov |
| July 15, 2022 | 90649 | Class II | Ongoing | (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x. | Inaccurate Distance and Area measurements with use of Global Stack viewport. | accessdata.fda.gov |
| June 24, 2022 | 90587 | Class II | Ongoing | SIGNA Premier magnetic resonance scanner, model 5748519. | Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss. | accessdata.fda.gov |
| June 14, 2022 | 90525 | Class II | Terminated | Centricity PACS Software Version 7.0 SP0.0.4.7 | The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. | accessdata.fda.gov |
| June 8, 2022 | 90454 | Class II | Ongoing | GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation. | Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) | accessdata.fda.gov |
| June 2, 2022 | 90368 | Class II | Ongoing | Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE | As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel. | accessdata.fda.gov |
| June 1, 2022 | 90424 | Class I | Terminated | GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000. | There is a potential reversal of the O2 and air cylinder pressure transducer connections. | accessdata.fda.gov |
| May 27, 2022 | 90422 | Class II | Ongoing | GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000. | The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person. | accessdata.fda.gov |
| May 10, 2022 | 90242 | Class II | Ongoing | CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUP | The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. | accessdata.fda.gov |
| April 28, 2022 | 90136 | Class II | Ongoing | Centricity Universal Viewer Zero Footprint Client | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution. | accessdata.fda.gov |
| April 25, 2022 | 90137 | Class II | Ongoing | Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019 | Backup batteries can fail earlier than their estimated life. | accessdata.fda.gov |
| April 18, 2022 | 90076 | Class I | Ongoing | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116) | Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. | accessdata.fda.gov |
| March 16, 2022 | 89834 | Class II | Terminated | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 | Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. | accessdata.fda.gov |
| March 4, 2022 | 89842 | Class II | Ongoing | GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR | During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury. | accessdata.fda.gov |
| February 18, 2022 | 89720 | Class II | Ongoing | Signa 1.5T TwinSpeed Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | accessdata.fda.gov |
| January 28, 2022 | 89576 | Class II | Ongoing | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001. | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. | accessdata.fda.gov |
| December 23, 2021 | 89376 | Class II | Ongoing | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system. | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | accessdata.fda.gov |
| November 4, 2021 | 89102 | Class II | Terminated | GE Vscan Extend, being sold as "Vscan Extend Console" | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. | accessdata.fda.gov |
| October 15, 2021 | 88959 | Class II | Terminated | GE Centricity Universal Viewer Zero Footprint Client | There is a potential to display incomplete patient imaging study. | accessdata.fda.gov |
| August 26, 2021 | 88665 | Class II | Terminated | SIGNA Premier nuclear magnetic resonance imaging system | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. | accessdata.fda.gov |
| August 12, 2021 | 88595 | Class II | Terminated | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system | A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA). | accessdata.fda.gov |
| August 6, 2021 | 88526 | Class II | Ongoing | Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive | accessdata.fda.gov |
| August 2, 2021 | 88400 | Class II | Ongoing | Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, c | The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient. | accessdata.fda.gov |
| June 30, 2021 | 89762 | Class II | Ongoing | Revolution Apex, Revolution CT with Apex Edition | The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high. | accessdata.fda.gov |
| June 30, 2021 | 89027 | Class II | Ongoing | Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered. | accessdata.fda.gov |
| June 30, 2021 | 88208 | Class II | Ongoing | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition. | accessdata.fda.gov |
| June 24, 2021 | 88601 | Class II | Terminated | AMX Navigate Mobile X-Ray System | An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system. | accessdata.fda.gov |
| June 14, 2021 | 88116 | Class II | Ongoing | Revolution EVO, Optima CT660, Optima CT680 CT Systems. | Improperly loaded software options may result in additional X -ray radiation exposure to the patient. | accessdata.fda.gov |
| June 4, 2021 | 88147 | Class II | Ongoing | SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons. | accessdata.fda.gov |
| May 21, 2021 | 88106 | Class II | Ongoing | CARESCAPE PDM-Masimo SpO2. Physiological data monitor. | Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. | accessdata.fda.gov |
| April 19, 2021 | 87863 | Class II | Terminated | GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional | The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen. | accessdata.fda.gov |
| April 19, 2021 | 87844 | Class II | Terminated | Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application | If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system. | accessdata.fda.gov |
| March 19, 2021 | 88150 | Class II | Completed | Revolution CT | GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value. | accessdata.fda.gov |
| March 19, 2021 | 87652 | Class II | Terminated | Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. | When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s). | accessdata.fda.gov |
| February 7, 2021 | 87811 | Class II | Ongoing | NM/CT 850 Nuclear Medicine / CT Scanners | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on t | accessdata.fda.gov |
| December 17, 2020 | 87089 | Class II | Terminated | System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition | GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge. | accessdata.fda.gov |
| December 10, 2020 | 87061 | Class II | Terminated | GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic r | GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or operator. | accessdata.fda.gov |
| December 10, 2020 | 87023 | Class II | Terminated | GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. | accessdata.fda.gov |
| November 23, 2020 | 86932 | Class II | Terminated | Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling | accessdata.fda.gov |
| October 27, 2020 | 86725 | Class II | Terminated | MAC VU360, Electrocardiograph | Incorrect patient identification and/or patient demographic errors. | accessdata.fda.gov |
| September 21, 2020 | 86544 | Class II | Terminated | Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings. | accessdata.fda.gov |
| September 17, 2020 | 86531 | Class II | Ongoing | Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR | Flow sensors could have damaged tubes in the form of small punctures or cuts. | accessdata.fda.gov |
| September 8, 2020 | 86452 | Class II | Terminated | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | accessdata.fda.gov |
| August 14, 2020 | 86337 | Class II | Terminated | NM/CT 850 Model Number: H3907AD | Rotor bearing screws were found loose on detector. | accessdata.fda.gov |
| July 14, 2020 | 86107 | Class II | Terminated | CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume | The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered. | accessdata.fda.gov |
| June 22, 2020 | 85979 | Class II | Terminated | CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hos | CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor. | accessdata.fda.gov |
| May 18, 2020 | 85765 | Class II | Ongoing | CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-04 | The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG | accessdata.fda.gov |
| April 28, 2020 | 85643 | Class II | Terminated | Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. | Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed. | accessdata.fda.gov |
| April 2, 2020 | 85536 | Class II | Terminated | Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. | During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor. | accessdata.fda.gov |
| December 23, 2019 | 84655 | Class II | Terminated | SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images. | accessdata.fda.gov |
| December 16, 2019 | 84584 | Class II | Terminated | Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources. | Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis. | accessdata.fda.gov |
| December 3, 2019 | 85466 | Class II | Ongoing | Lunar iDXA bone densitometer | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. | accessdata.fda.gov |
| November 25, 2019 | 84438 | Class I | Terminated | Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. | GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene. | accessdata.fda.gov |
| November 12, 2019 | 84372 | Class II | Terminated | ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological d | When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack. | accessdata.fda.gov |
| October 11, 2019 | 84077 | Class I | Terminated | Giraffe OmniBed infant warmer | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall. | accessdata.fda.gov |
| September 27, 2019 | 84034 | Class I | Terminated | CARESCAPE Respiratory Module E-sCO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values. | accessdata.fda.gov |
| September 16, 2019 | 83899 | Class II | Terminated | CardioLab/ComboLab Recording Systems | Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient. | accessdata.fda.gov |
| September 3, 2019 | 83811 | Class II | Terminated | Achilles Insight Bone Sonometer | Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection. | accessdata.fda.gov |
| August 30, 2019 | 83813 | Class II | Ongoing | ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or | May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions. | accessdata.fda.gov |
| August 9, 2019 | 83647 | Class II | Ongoing | Proteus XR/a (SlOK : K993090) | Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. | accessdata.fda.gov |
| July 26, 2019 | 83532 | Class II | Ongoing | Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same t | Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall. | accessdata.fda.gov |
| July 19, 2019 | 83425 | Class II | Terminated | Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1 | Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters. | accessdata.fda.gov |
| July 2, 2019 | 83271 | Class II | Terminated | Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D | Potential for a transducer mis-alignment in certain transvaginal probes. | accessdata.fda.gov |
| June 28, 2019 | 83270 | Class II | Terminated | MAC VU360, Model Number 2030360-001, Electrocardiograph | Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being | accessdata.fda.gov |
| May 22, 2019 | 83002 | Class II | Terminated | GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x | There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer. | accessdata.fda.gov |
| May 21, 2019 | 82938 | Class II | Ongoing | LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b.Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Number | Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product. | accessdata.fda.gov |
| May 17, 2019 | 83036 | Class II | Terminated | Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other hea | There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. | accessdata.fda.gov |
| May 16, 2019 | 83096 | Class II | Terminated | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the sa | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | accessdata.fda.gov |
| May 16, 2019 | 82998 | Class II | Terminated | Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. | accessdata.fda.gov |
| May 10, 2019 | 82937 | Class III | Terminated | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2 | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. | accessdata.fda.gov |
| March 29, 2019 | 82668 | Class II | Terminated | Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system. | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. | accessdata.fda.gov |
| March 20, 2019 | 82582 | Class II | Terminated | Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the pati | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy. | accessdata.fda.gov |
| March 19, 2019 | 83814 | Class II | Terminated | AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems. | The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected. | accessdata.fda.gov |
| March 15, 2019 | 82514 | Class II | Ongoing | Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. | There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously. | accessdata.fda.gov |
| March 15, 2019 | 82485 | Class I | Terminated | Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilit | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle. | accessdata.fda.gov |
| February 22, 2019 | 82272 | Class III | Terminated | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT | The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient. | accessdata.fda.gov |
| February 12, 2019 | 82982 | Class II | Ongoing | Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of i | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | accessdata.fda.gov |
| January 19, 2019 | 83254 | Class II | Ongoing | Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | Additional low dose radiation exposure. | accessdata.fda.gov |
| December 28, 2018 | 81937 | Class II | Terminated | GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatr | Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes. | accessdata.fda.gov |
| December 20, 2018 | 81975 | Class II | Terminated | GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical | When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis. | accessdata.fda.gov |
| November 30, 2018 | 85746 | Class II | Ongoing | System, Tomography Computed Emmission | GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current. | accessdata.fda.gov |
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Updated July 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.