Device recall
Z-1801-2010: GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1…
FDA device recall · Class II · Ge Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-1801-2010 |
|---|---|
| Recall event | 55352 |
| Product | GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult… |
| Product code | MHX |
| Recalling firm | Ge Healthcare, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2012 |
| 510(k) numbers | K092927 |
| 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