Data / Medical devices / China / Ge Medical Systems (china) Co., Ltd.
Ge Medical Systems (china) Co., Ltd.: FDA-registered device maker in WUXI Jiangsu, China, 131 510(k) clearances and 1 PMA approval
Ge Medical Systems (china) Co., Ltd. is registered with the FDA (registration 9710602) in WUXI Jiangsu, China. It lists 57 device types. The FDA files 131 510(k) clearances and 1 PMA approval under its listings, the newest dated October 2, 2026. 7 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9710602
- FEI number
- 3003513129
- Address
- No. 19 Changjiang Road National Hi-Tech Dev. Zone, WUXI Jiangsu, China, 214028
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- July 11, 1995
- Registered through
- 2027
- Brand names listed
- 10-D, 10L, 10T-D, 11L, 11L-D, 11M3, 12L, 12L-RS 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. Newest 100 of 131.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2026 | K261933 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | accessdata.fda.gov |
| September 2, 2026 | K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 7, 2026 | K261668 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | accessdata.fda.gov |
| July 30, 2026 | K261835 | LOGIQ Focus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 24, 2026 | K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| May 26, 2026 | K260398 | LOGIQ e | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 24, 2026 | K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 26, 2026 | K251670 | MAC 7 Resting ECG Analysis System | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| January 8, 2026 | K253370 | LOGIQ Totus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 7, 2026 | K253366 | LOGIQ Fortis | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 24, 2025 | K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 29, 2025 | K251985 | LOGIQ E10 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 29, 2025 | K251963 | LOGIQ E10s | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 25, 2025 | K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 10, 2025 | K251169 | Vivid Pioneer | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 29, 2025 | K250543 | Voluson Performance 16; Voluson Performance 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 11, 2025 | K243628 | Vivid T9/Vivid T8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 11, 2025 | K243620 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 20, 2024 | K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 2, 2024 | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240206 | Venue Sprint | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240111 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240053 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K234106 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 25, 2024 | K233810 | Portrait VSM | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| March 7, 2024 | K233692 | Voluson Signature 20, Voluson Signature 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 7, 2023 | K232381 | LOGIQ Totus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 7, 2023 | K231989 | LOGIQ E10s, LOGIQ Fortis | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | accessdata.fda.gov |
| November 7, 2023 | K231966 | LOGIQ E10 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 3, 2023 | K232186 | LOGIQ e | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | accessdata.fda.gov |
| October 30, 2023 | K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 20, 2023 | K230346 | Voluson SWIFT; Voluson SWIFT+ | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | accessdata.fda.gov |
| April 6, 2023 | K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| March 28, 2023 | K213867 | Carestation 750/750c | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| February 16, 2023 | K223832 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | Ge Medical System Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 15, 2023 | K223407 | Versana Essential | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 18, 2022 | K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| July 22, 2022 | K220882 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 18, 2022 | K221148 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| July 18, 2022 | K221147 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 15, 2022 | K220619 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 27, 2022 | K220851 | Venue | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 27, 2022 | K220848 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 21, 2022 | K220800 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 6, 2022 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 11, 2022 | K220446 | Versana Balance | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 1, 2022 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| March 22, 2022 | K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 17, 2022 | K213689 | Voluson P6, Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 13, 2022 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 4, 2021 | K210384 | CARESCAPE R860 | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| September 10, 2021 | K211488 | LOGIQ E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 10, 2021 | K210438 | Versana Premier | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 27, 2021 | K211524 | LOGIQ E10s, LOGIQ Fortis | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 9, 2021 | K211216 | Vivid S60N / Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 30, 2021 | K203786 | MAC 7 - Resting ECG Analysis System | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| March 5, 2021 | K202658 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 8, 2021 | K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 29, 2020 | K203137 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 18, 2020 | K202233 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 13, 2020 | K202132 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 11, 2020 | K201828 | Voluson SWIFT, Voluson SWIFT+ | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 9, 2020 | K200851 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 9, 2020 | K200708 | Vivid iq | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 23, 2020 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 16, 2020 | K200497 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 1, 2020 | K200138 | Versana Premier | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| June 11, 2020 | K200998 | Versana Active | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 1, 2020 | K200119 | LOGIQ E10s | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 29, 2019 | K192159 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 9, 2019 | K191798 | Versana Active | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 9, 2019 | K191792 | Versana Balance | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 28, 2019 | K183362 | Venue GO | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 6, 2018 | K181727 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 21, 2018 | K182277 | Versana Premier | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 15, 2018 | K181985 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 6, 2018 | K181934 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| October 25, 2018 | K181685 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 19, 2018 | K182450 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 20, 2018 | K181783 | LOGIQ P9; LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 25, 2018 | K180995 | Vscan Extend | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 4, 2018 | K180641 | Invenia ABUS Viewer | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 2, 2018 | K180599 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 29, 2018 | K180535 | Voluson P6 and Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 13, 2018 | K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 2, 2017 | K173341 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| September 29, 2017 | K172342 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 21, 2017 | K170714 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| June 14, 2017 | K170878 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| June 12, 2017 | K170823 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 11, 2017 | K170445 | LOGIQ S8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 10, 2017 | K163596 | LOGIQ P9 and LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 17, 2016 | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 3, 2016 | K162269 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 31, 2016 | K161588 | Vscan Extend | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| August 5, 2016 | K161706 | Vivid iq | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | accessdata.fda.gov |
| August 5, 2016 | K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| May 5, 2016 | K161047 | LOGIQ P9 and LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 26, 2016 | K160162 | Voluson P6, Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 25, 2016 | K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 18, 2012 | P110006 | SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) | PAA | 11 | February 4, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 21, 2026 | 98917 | Class II | Ongoing | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph | Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making. | accessdata.fda.gov |
| November 14, 2025 | 98064 | Class I | Ongoing | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 101 | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC po | accessdata.fda.gov |
| May 16, 2025 | 96992 | Class II | Ongoing | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation. | accessdata.fda.gov |
| March 21, 2025 | 96634 | Class I | Ongoing | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | accessdata.fda.gov |
| September 8, 2023 | 93054 | Class II | Ongoing | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days. | accessdata.fda.gov |
| July 24, 2018 | 80693 | Class II | Terminated | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could | accessdata.fda.gov |
| October 11, 2017 | 78469 | Class II | Ongoing | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Automated Radiological Image Processing Software
- All makers of Twister, Brace Setting
- All makers of Incubator, Neonatal
Updated October 2, 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.