Device recall
Z-1616-2020: Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1616-2020 |
|---|---|
| Recall event | 85090 |
| Product | Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients… |
| Product code | MWI |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2021 |
| 510(k) numbers | K152330 |
| 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