Recall Z-1665-2009 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems North America Co. Phillips
OmniDiagnost
| Date | Sep 24, 2009 (initiated Jul 6, 2009) |
| Status | Terminated |
| Reason | The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009. |
| Quantity | 28 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982993 | PHILIPS OMNIDIAGNOST Philips Medical Systems, Inc., Sep 29, 1998 |