Device recall
Z-2369-2008: Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring…
FDA device recall · Class III · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-2369-2008 |
|---|---|
| Recall event | 49005 |
| Product | Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: B.02.07 Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient. |
| Product code | DQA |
| Recalling firm | Philips Medical Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 16, 2012 |
| 510(k) numbers | K041674 |
| FEI number | 1218950 |
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