Drug recall
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00…
FDA recall event 85090 · Class II · Philips North America, LLC
Key facts
| Event ID | 85090 |
|---|---|
| Recall numbers | Z-1616-2020 |
| Recalling firm | Philips North America, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2… |
| Initiation date | Feb 20, 2020 |
| Report date | Apr 8, 2020 |
| Termination date | Sep 21, 2021 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1218950 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: