Device recall
Z-0453-2026: Carescape B450, Model no. 5805686 - shipped with potentially affected batteries…
FDA device recall · Class II · GE Healthcare Finland Oy
Key facts
| Recall number (Z-number) | Z-0453-2026 |
|---|---|
| Recall event | 97786 |
| Product | Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL)… |
| Product code | MHX |
| Recalling firm | GE Healthcare Finland Oy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213363 |
| FEI number | 3002806783 |
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