Device recall
Z-2134-2011: Ultraview SL Patient Monitor, Model 91387. All modules may be affected except…
FDA device recall · Class II · Spacelabs Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-2134-2011 |
|---|---|
| Recall event | 58402 |
| Product | Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx). The data sheet is labeled in part: "***91387-27 SL2700… |
| Product code | MHX |
| Recalling firm | Spacelabs Healthcare, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2012 |
| 510(k) numbers | K102422 |
| FEI number | 3010157426 |
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