Device recall
Z-1577-2015: Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN…
FDA device recall · Class II · Spacelabs Healthcare Inc
Key facts
| Recall number (Z-number) | Z-1577-2015 |
|---|---|
| Recall event | 71118 |
| Product | Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in… |
| Product code | DSI |
| Recalling firm | Spacelabs Healthcare Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2015 |
| 510(k) numbers | K103142 |
| FEI number | 3010157426 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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