Recall Z-0022-2015 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Medical Systems, Inc.
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
| Date | Oct 9, 2014 (initiated Aug 8, 2014) |
| Status | Terminated |
| Reason | Philips had discovered through a field service testing where a device failed to comply with a Federal standard. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Healthcare discovered through field service testing, that the device was in violation. Firm service rep. visited site on 7/01/14 and corrected unit. The field service engineer immediately reprogrammed the generator for the X-ray tube installed in the system and re-adapted the x-ray tube to bring the system back into compliance. At this time the Failure to comply has been corrected and the customer has been notified. This correction is to be free of charge to the customer. For further questions please call (978) 687-1501. |
| Quantity | one system |
| Distribution | US distribution to FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002016 | PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc., Sep 6, 2000 |