Device recall
Z-1227-2022: Replacement back up batteries distributed on or after April 1, 2019, for…
FDA device recall · Class I · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1227-2022 |
|---|---|
| Recall event | 90076 |
| Product | Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators. |
| 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