Carestation 750 anesthesia systems recalled over potential unexpected shutdown
GE Medical Systems is recalling 888 Carestation 750 series anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The action is Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
GE Healthcare Carestation anesthesia systems are being recalled, covering the Carestation 750 A1 (REF 1012-9750-000), 750 A2 (REF 1012-9750-002) and 750c A1 (REF 1012-9755-000), together with products for which the affected power management board can be used.
There is a potential for 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 the 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 battery supply mode and will reboot. GE states that a temporary disruption of mechanical ventilation, manual ventilation and volatile agent delivery may occur, and that following the reboot the system will not return to the previous ventilation settings.
The record lists 888 units. Distribution was worldwide, including nationwide in the United States and to a wide range of other countries. The FDA has classified the action as Class I, its most serious category.
Facilities should follow GE's instructions immediately.
The recalled product
- Product
- 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: Carestatio
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- unexpected-shutdown
- power-failure
- ventilation-disruption
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- REF 1012-9750-000: GTIN 00840682145596
- REF 1012-9750-002: GTIN 00840682146470
- REF 1012-9755-000: GTIN 00840682146425
- REF 1012-9755-002: GTIN 00840682146463.
Distribution
Distributed nationwide across the United States.
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