ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
FDA device recall Z-0727-2021 · posted 2021-01-28 · Terminated
Recall details
- Recalling firm
- PHILIPS HOME HEALTHCARE SOLUTION
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 91
- Distribution
- Nationwide
- Date initiated
- 2020-12-08
- Date posted
- 2021-01-28
- Date terminated
- 2024-06-21
- Location
- Cambridge, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ProxiDiagnost N90 (K173433) | Philips Medical Systems Dmc GmbH | 2018-02-05 |