[pending] GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Pending LLM rewrite. Source: FDA_DEVICE Z-1624-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Category
- Medical Device — Devices
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 (20)
- GTIN 00840682103985
- Serial Numbers: SM623390002MA
- SM623390003MA
- SM623020017MA
- SM623480018MA
- SM623480019MA
- SM623480020MA
- SM623480021MA
- SM623110013MA
- SM623060017MA
- SM623060018MA
- SM623060019MA
- SM623060020MA
- SM624440004MA
- SM624440005MA
- SM623320003MA
- SM624050005MA
- SM624050006MA
- SM624130001MA
- SM624200013MA
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27