Device recall
Z-2211-2009: Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits…
FDA device recall · Class II · Spacelabs Healthcare, Incorporated
Key facts
| Recall number (Z-number) | Z-2211-2009 |
|---|---|
| Recall event | 53124 |
| Product | Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23… |
| Product code | MHX |
| Recalling firm | Spacelabs Healthcare, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2011 |
| 510(k) numbers | K090556 |
| 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