CombiDiagnost R90 is multi-functional general R/F systems — Class II medical device recall Z-0241-2022
Ongoing recall by Philips Healthcare, reported 2021-12-01, distributed nationwide. The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product
| Recall number | Z-0241-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Healthcare, Andover, MA, United States |
| Recall initiated | 2021-09-22 |
| Classified | 2021-11-24 |
| Reported by FDA | 2021-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 281 in |
| Reason classes | labeling |
Product
CombiDiagnost R90 is multi-functional general R/F systems.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0241-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.