Device recall
Z-2812-2020: Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-2812-2020 |
|---|---|
| Recall event | 86025 |
| Product | Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. |
| Product code | MWI |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2023 |
| 510(k) numbers | K090785, K131382 |
| FEI number | 1218950 |
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