FDA Device recall Z-0727-2021
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system by Philips Home Healthcare Solution, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0727-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-08 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Home Healthcare Solution |
| Distribution | US |
Product
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Reason
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.
Identifiers
| code_info | Pending |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0727-2021%22
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