Wuxi, China
GE Medical Systems China Co., Ltd. recalls
7 recalls recorded since 2018, most recently on 21 April 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)6
Terminated or completed1
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 21 April 2026
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2306-2026
- MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Ongoing Class I Medical devices
- Recall started
- 14 November 2025
- Reason
- 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 power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, H
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0913-2026, Z-0914-2026, Z-0915-2026
- 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 A
- GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for w
- GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Ongoing Class II Medical devices
- Recall started
- 16 May 2025
- Reason
- 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.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2029-2025, Z-2030-2025
- GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
- GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3
Ongoing Class I Medical devices
- Recall started
- 21 March 2025
- Reason
- 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.
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1625-2025, Z-1632-2025, Z-1636-2025, Z-1630-2025, Z-1627-2025, Z-1629-2025, Z-1633-2025, Z-1626-2025, Z-1638-2025, Z-1628-2025, Z-1631-2025, Z-1635-2025 and 3 more
- GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
- GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
- GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
- GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
- GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
- GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
- GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
- GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
- and 7 more product lines
Ongoing Class II Medical devices
- Recall started
- 8 September 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Ar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2656-2023
- F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Terminated Class II Medical devices
- Recall started
- 24 July 2018
- Terminated
- 16 December 2020
- Reason
- 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 lead to hypoxia.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2954-2018, Z-2955-2018, Z-2956-2018
- GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
- GE Carestation 30 anesthesia systems
- GE 9100c NXT anesthesia systems
Ongoing Class II Medical devices
- Recall started
- 11 October 2017
- Reason
- Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
- Distribution
- Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV. Distributed internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bo
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0580-2018, Z-0579-2018
- Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
- Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.