Philips Healthcare Recall 89023
Description: CombiDiagnost R90 is multi-functional general R/F systems.
Philips Healthcare Recall 89023 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0241-2022 |
| Event ID | 89023 |
| Event Description | CombiDiagnost R90 is multi-functional general R/F systems. |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 281 in total |
| Recall Reason | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied. |
| Device Classification | 20211201 |
| Device Code Info | CombiDiagnost R90 |
| Center Classification Date | 20211124 |
| Recall Initiation Date | 20210922 |
| Recalling Firm | Philips Healthcare |
| Initial Notification | Letter |
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