FDA Device recall Z-0915-2026
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
- FDA Device
- Class I
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class I recall of GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S by Ge Medical Systems China, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0915-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-11-14 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems China |
| Distribution | US |
Product
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
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.
Identifiers
| code_info | FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-06-10 · Ge Medical Systems China - GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China - GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China - GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China - GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog…
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China
All Ge Medical Systems China recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0915-2026%22
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