FDA Recall
Terminated
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Recall: Z-0022-2015
·
Initiated August 8, 2014
Recall
- Recall Number
- Z-0022-2015
- Event Number
- 69197
- Firm
- Philips Medical Systems, Inc.
- FEI Number
- 1218950
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- August 8, 2014
- Posted
- October 9, 2014
- Terminated
- December 3, 2014
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Reason
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
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.
Distribution
US distribution to FL
Quantity
one system