CLASS I ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report

GE Healthcare Carestation anesthesia system, product number recalled

GE Medical Systems China is recalling GE Healthcare Carestation anesthesia system, product number, distributed nationwide in the US. The recall was initiated on 14 Nov 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesREF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463.

Quantity recalled888 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0914-2026
FDA event ID: 98064
Recalling firm: GE Medical Systems China, Wuxi
Classification: Class I
Status: Ongoing
Recall initiated: 14 Nov 2025
FDA classified: 18 Dec 2025
Reported: 24 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Nov 2025	Recall initiated by company
18 Dec 2025	Classified by FDA	+34 days
24 Dec 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

REF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 98064

This product is part of a recall event; the main page for the event is GE Healthcare Carestation anesthesia system, product number recalled.

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025	CLASS I	GE Healthcare Carestation anesthesia system, product number recalled	GE Medical Systems China	Device Malfunction	Nationwide
24 Dec 2025	CLASS I	GE Healthcare Carestation anesthesia system Power recalled	GE Medical Systems China	Device Malfunction	Nationwide

More recalls from GE Medical Systems China

All 25

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10 Jun 2026Device	CLASS II	MAC 5 A4 Resting ECG Analysis System recalled	GE Medical Systems China	Device Malfunction	Nationwide
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7 May 2025Device	CLASS I	GE Healthcare Carestation 650c A1 recalled	GE Medical Systems China	Other	Nationwide

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