FDA Device recall Z-0241-2022
CombiDiagnost R90 is multi-functional general R/F systems
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of CombiDiagnost R90 is multi-functional general R/F systems by Philips Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0241-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-22 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
CombiDiagnost R90 is multi-functional general R/F systems.
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.
Identifiers
| code_info | CombiDiagnost R90 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0241-2022%22
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