Data / Medical devices / United States / Ge Healthcare
Ge Healthcare: FDA-registered device maker in Chicago, IL, United States, 21 510(k) clearances
Ge Healthcare is registered with the FDA (registration 3004526608) in Chicago, IL, United States. It lists 8 device types. The FDA files 21 510(k) clearances under its listings, the newest dated January 8, 2026. 61 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004526608
- Address
- 500 W. Monroe Street, Chicago, IL, United States, 60661
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 6, 2000
- Registered through
- 2027
- Brand names listed
- CRC, CareIntellect Perinatal, Centricity AW Suite, Centricity Cardio Imaging, Centricity Cardiology CA1000 v1, Centricity PACS, Centricity PACS (RA1000), Centricity PACS (RA1000) 4.x and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Manufacturer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Specification developer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| January 8, 2026 | K253639 | View | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 1, 2025 | K242925 | MR Contour DL | QKB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 27, 2023 | K232346 | Digital Expert Access with Remote Scanning | LNH | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 21, 2022 | K222586 | Mural Clinical Viewer | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| August 25, 2022 | K211841 | MRI Planner | MUJ | Substantially Equivalent | Spectronic Medical AB | accessdata.fda.gov |
| June 23, 2022 | K220732 | Mural Perinatal Surveillance | HGM | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| May 21, 2021 | K211312 | Universal Viewer | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 14, 2018 | K182419 | Centricity Universal Viewer | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 26, 2015 | K150420 | Centricity Universal Viewer | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 24, 2015 | K150193 | Customer Remote Console (CRC) | LLZ | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 17, 2013 | K131977 | CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 16, 2012 | K123174 | CENTRICITY PACS-IW WITH UNIVERSAL VIEWER | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 5, 2012 | K121387 | CENTRICITY PACS-IW | LLZ | Substantially Equivalent | Ge Healthcare Integrated IT Solutions | accessdata.fda.gov |
| November 30, 2011 | K112570 | CENTRICITY CARDIO IMAGING | LLZ | Substantially Equivalent | Ge Healthcare Integrated IT Solutions | accessdata.fda.gov |
| September 26, 2011 | K111614 | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE | HGM | Substantially Equivalent | Ge Healthcare Integrated IT Solutions | accessdata.fda.gov |
| May 5, 2011 | K110875 | CENTRICITY PACS | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 14, 2008 | K083018 | CENTRICITY PACS WEB DIAGNOSTIC | LLZ | Substantially Equivalent | Ge Healthcare Dynamic Imaging Solutions | accessdata.fda.gov |
| August 25, 2008 | K082318 | CENTRICITY PACS IW | LLZ | Substantially Equivalent | Ge Healthcare Dynamic Imaging Solutions | accessdata.fda.gov |
| December 26, 2006 | K063628 | CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY | LLZ | Substantially Equivalent | Ge Healthcare Integrated IT Solutions | accessdata.fda.gov |
| May 30, 2006 | K061372 | CENTRICITY AW SUITE OPTION | LLZ | Substantially Equivalent | Ge Healthcare Information Technologies | accessdata.fda.gov |
| October 1, 2004 | K042525 | CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION | LLZ | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | 99661 | Class II | Ongoing | Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care. | accessdata.fda.gov |
| January 16, 2026 | 98368 | Class II | Ongoing | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological | Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed | accessdata.fda.gov |
| February 19, 2025 | 96375 | Class II | Ongoing | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-1 | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate pati | accessdata.fda.gov |
| October 3, 2024 | 95512 | Class II | Ongoing | GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Univer | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data. | accessdata.fda.gov |
| August 29, 2024 | 95307 | Class II | Ongoing | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a) 2089507-120; b) 2089507-129; c) 2089507-131; d) 2089507-135; e) 2089507-136; f) 2089507-140; g) 2089507-144; h) 2089507-145; | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series. | accessdata.fda.gov |
| August 5, 2024 | 95243 | Class II | Ongoing | GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. | GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. | accessdata.fda.gov |
| July 23, 2024 | 95238 | Class II | Ongoing | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-0 | Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox. | accessdata.fda.gov |
| September 14, 2023 | 93099 | Class II | Ongoing | Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System | GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation. | accessdata.fda.gov |
| September 8, 2023 | 93053 | Class II | Ongoing | Centricity Universal Viewer Workflow Manager, Image processing radiological system | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer. | accessdata.fda.gov |
| March 28, 2023 | 92062 | Class II | Ongoing | Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System | GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. | accessdata.fda.gov |
| February 23, 2018 | 79537 | Class II | Terminated | GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various im | A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. 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 indication to the user. While this is rare, this can occur with imaging studies that cons | accessdata.fda.gov |
| January 25, 2018 | 80159 | Class II | Terminated | Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and da | Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. | accessdata.fda.gov |
| September 28, 2015 | 72472 | Class II | Terminated | The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed wit | Inaccurate distance measurements with magnified projection X-ray images. | accessdata.fda.gov |
| September 16, 2015 | 72212 | Class II | Terminated | Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed | Images may be missing when a system parameter MapRoute is set to a value greater than 1. | accessdata.fda.gov |
| August 11, 2015 | 71964 | Class II | Terminated | Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the accep | Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1. | accessdata.fda.gov |
| April 3, 2014 | 68092 | Class II | Terminated | The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and n | It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If | accessdata.fda.gov |
| August 26, 2013 | 65366 | Class II | Terminated | Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices | There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This incorrect image display issue could result in an inaccurate reading on the Merge Mammo workstation. This could result in | accessdata.fda.gov |
| June 11, 2013 | 65471 | Class II | Terminated | The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and n | GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Inte | accessdata.fda.gov |
| April 19, 2013 | 64760 | Class II | Terminated | Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by | GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full. | accessdata.fda.gov |
| March 12, 2013 | 64807 | Class II | Terminated | The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and fa | GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument | accessdata.fda.gov |
| March 12, 2013 | 64806 | Class II | Terminated | The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and fa | GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of on | accessdata.fda.gov |
| March 11, 2013 | 64805 | Class II | Terminated | Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units i | 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient dat | accessdata.fda.gov |
| February 18, 2013 | 64784 | Class II | Terminated | The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and n | Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp | accessdata.fda.gov |
| February 18, 2013 | 64758 | Class II | Terminated | Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses an | A software defect was discovered that causes images to be out of context with clinical information. | accessdata.fda.gov |
| February 18, 2013 | 64545 | Class II | Terminated | Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer | It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder. | accessdata.fda.gov |
| November 20, 2012 | 64796 | Class II | Terminated | Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilizat | The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num. | accessdata.fda.gov |
| November 20, 2012 | 64795 | Class III | Terminated | The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and fa | GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 | accessdata.fda.gov |
| November 20, 2012 | 64789 | Class II | Terminated | The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and fa | If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be | accessdata.fda.gov |
| November 16, 2012 | 64761 | Class II | Terminated | Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstat | There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the | accessdata.fda.gov |
| November 15, 2012 | 64785 | Class II | Terminated | GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, includ | While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random im | accessdata.fda.gov |
| October 2, 2012 | 64787 | Class II | Terminated | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Ca | GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differ | accessdata.fda.gov |
| September 15, 2012 | 64724 | Class II | Terminated | Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare p | There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a part | accessdata.fda.gov |
| June 15, 2012 | 64730 | Class II | Terminated | Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed | Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under report | accessdata.fda.gov |
| April 19, 2012 | 64762 | Class II | Terminated | The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the | GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by C | accessdata.fda.gov |
| May 3, 2011 | 58676 | Not yet classified | Terminated | GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity Laboratory is designed to facilitate the general clinical, a | The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted. | accessdata.fda.gov |
| March 4, 2011 | 64740 | Class II | Terminated | Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardwa | In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) Pixel Spacing and, (0018,1164) Imager Pixel Spacing. Because the estimated magnificati | accessdata.fda.gov |
| December 3, 2010 | 57379 | Not yet classified | Terminated | GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such | The GE Centricity Laboratory System Software has safety issues with the "Telephone List" function, the "Anatomic Pathology" application, and the Instrument Interface IO module that may impact patient safety. | accessdata.fda.gov |
| August 27, 2010 | 56627 | Not yet classified | Terminated | GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathol | Instrument may incorrectly report the result of an antimicrobial sensitivity test. | accessdata.fda.gov |
| May 26, 2010 | 55868 | Not yet classified | Terminated | GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology labo | There is a potential safety issue associated with the use of GE Centricity Laboratory software where results from interfaced external reference laboratories are not displayed or stored correctly. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the test result sent from the reference lab includes a comma in | accessdata.fda.gov |
| February 18, 2010 | 55040 | Not yet classified | Terminated | GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging | There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers. | accessdata.fda.gov |
| February 11, 2010 | 55037 | Not yet classified | Terminated | GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources. | There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety. | accessdata.fda.gov |
| September 25, 2009 | 53462 | Not yet classified | Terminated | GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display | There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety. | accessdata.fda.gov |
| August 14, 2009 | 52858 | Not yet classified | Terminated | Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radi | Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive. | accessdata.fda.gov |
| April 3, 2009 | 51501 | Not yet classified | Terminated | GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit | There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images. | accessdata.fda.gov |
| March 24, 2009 | 51252 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is | Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue. | accessdata.fda.gov |
| January 12, 2009 | 50758 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is intended | If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars. | accessdata.fda.gov |
| December 12, 2008 | 50540 | Not yet classified | Terminated | Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solu | Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session, and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation. | accessdata.fda.gov |
| December 12, 2008 | 50538 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis | There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. | accessdata.fda.gov |
| November 21, 2008 | 50539 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis | There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. | accessdata.fda.gov |
| November 20, 2008 | 50759 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is intended | Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam. | accessdata.fda.gov |
| November 17, 2008 | 50201 | Not yet classified | Terminated | Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the g | A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result. | accessdata.fda.gov |
| September 25, 2008 | 49460 | Not yet classified | Terminated | GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby a | Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations. | accessdata.fda.gov |
| September 25, 2008 | 49459 | Not yet classified | Terminated | Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neon | On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy. | accessdata.fda.gov |
| September 25, 2008 | 49458 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysi | Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image titl | accessdata.fda.gov |
| September 22, 2008 | 49517 | Not yet classified | Terminated | GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010. | Software computer, error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. For further information, please telephone GE Healthcare Integrated IT Solutions at. | accessdata.fda.gov |
| June 30, 2008 | 48755 | Not yet classified | Terminated | GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neo | Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file. | accessdata.fda.gov |
| June 11, 2008 | 48637 | Not yet classified | Terminated | GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 | When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space b | accessdata.fda.gov |
| May 9, 2008 | 47840 | Not yet classified | Terminated | GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 | Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations. | accessdata.fda.gov |
| May 6, 2008 | 48078 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 | A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis. | accessdata.fda.gov |
| December 28, 2007 | 46306 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 | Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open. | accessdata.fda.gov |
| January 12, 2007 | 37121 | Not yet classified | Terminated | GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 | The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential. | accessdata.fda.gov |
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Updated September 15, 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.