Device recall
Z-0987-2011: Physiological Monitoring, Patient Monitor M31250 Information Center Local…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-0987-2011 |
|---|---|
| Recall event | 57501 |
| Product | Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is to display… |
| Product code | MHX |
| Recalling firm | Philips Healthcare Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2017 |
| 510(k) numbers | K081983 |
| 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