Device recall
Z-0304-2012: Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model…
FDA device recall · Class II · Del Mar Reynolds Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-0304-2012 |
|---|---|
| Recall event | 60204 |
| Product | Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. |
| Product code | DXN |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2012 |
| 510(k) numbers | K103732 |
| FEI number | 3002807992 |
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