Device recall
Z-1226-2022: Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860…
FDA device recall · Class I · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1226-2022 |
|---|---|
| Recall event | 90076 |
| Product | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116) |
| Product code | CBK |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K111116, K142679 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database