Device recall
Z-0100-2009: M3811B Philips Telemonitoring Clinical Review Software part of Philips…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0100-2009 |
|---|---|
| Recall event | 49402 |
| Product | M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over… |
| Product code | DQA |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2017 |
| 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