Severity
Critical
FDA Devices recall · Reported December 24, 2025
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 o…
Ge Medical Systems China Co., Ltd. recalled GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestati… - a critical-severity action.
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestati… was recalled by Ge Medical Systems China Co., Ltd. in December 24, 2025. Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power m…. Check the official notice for the remedy. Verify recall #Z-0914-2026 with the FDA Devices before acting.
The recall
Ge Medical Systems China Co., Ltd. issued this critical-severity FDA Devices recall-Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power m….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0914-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0914-2026) was formally reported on December 24, 2025, with the manufacturer initiating the action on November 14, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Ge Medical Systems China Co., Ltd. is listed as the recalling firm, operating out of Wuxi. Federal records list the affected scope as 888 units.
The documented reason for this recall is: 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. Anesthes… Distribution data in the federal record shows the product reached: 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, Domini…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
888 units
Related Recalls
6
3 from same agency
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 which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0914-2026 |
| Date reported | December 24, 2025 |
| Date initiated | November 14, 2025 |
| Recalling firm | Ge Medical Systems China Co., Ltd. |
| Firm location | Wuxi |
| Affected scope | 888 units |
| 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, Ecuado… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 24, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.