Device recall
Z-0455-2026: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002…
FDA device recall · Class II · GE Healthcare Finland Oy
Key facts
| Recall number (Z-number) | Z-0455-2026 |
|---|---|
| Recall event | 97786 |
| Product | B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add… |
| Product code | MHX |
| Recalling firm | GE Healthcare Finland Oy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213490 |
| 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