CombiDiagnost R90 Software Version R1 — Class II medical device recall Z-2357-2021
Ongoing recall by Philips Medical Systems Gmbh, DMC, reported 2021-09-08, distributed nationwide. Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change
| Recall number | Z-2357-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Medical Systems Gmbh, DMC, Hamburg, N/A, Germany |
| Recall initiated | 2020-07-22 |
| Classified | 2021-08-28 |
| Reported by FDA | 2021-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 322 systems |
| Reason classes | software |
| Model numbers | 706100 |
Product
CombiDiagnost R90 Software Version R1.0 and R1.1
Reason for recall
Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
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-2357-2021. 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.