ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system — Class II medical device recall Z-0727-2021
Terminated recall by PHILIPS HOME HEALTHCARE SOLUTION, reported 2021-02-03, distributed nationwide. After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if
| Recall number | Z-0727-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | PHILIPS HOME HEALTHCARE SOLUTION, Cambridge, MA, United States |
| Recall initiated | 2020-12-08 |
| Classified | 2020-12-31 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2024-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 91 |
Product
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Reason for recall
After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
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-0727-2021. 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.