FDA Device recall Z-1626-2025
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
- FDA Device
- Class I
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class I recall of GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 by Ge Medical Systems China, citing 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, effect….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1626-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-03-21 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems China |
| Distribution | US |
Product
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
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.
Identifiers
| code_info | GTIN 00195278569677, Serial Numbers: SM624250018WC, SM624250019WC, SM624500025WC, SM624500026WC, SM624500027WC, SM6242…GTIN 00195278569677, Serial Numbers: SM624250018WC, SM624250019WC, SM624500025WC, SM624500026WC, SM624500027WC, SM624290020WC, SM624290021WC, SM623470001WC, SM623470002WC, SM623470003WC, SM623470004WC, SM623470005WC, SM623470006WC, SM623470007WC, SM623470008WC, SM623470009WC, SM623470010WC, SM623470011WC, SM623470012WC, SM624240017WC, SM624240013WC, SM624240014WC, SM624240015WC, SM624240016WC, SM624110001WC, SM624330022WC, SM624330023WC. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Ge Medical Systems China
- MAC 5 A4 Resting ECG Analysis System 855001-001
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 Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
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
All Ge Medical Systems China recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1626-2025%22
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