Recall Z-0727-2021 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS HOME HEALTHCARE SOLUTION
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
| Date | Jan 28, 2021 (initiated Dec 8, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Quantity | 91 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173433 | ProxiDiagnost N90 Philips Medical Systems Dmc GmbH, Feb 5, 2018 |