Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
This recall has been terminated (originally issued October 9, 2014).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- August 8, 2014
- Posted
- October 9, 2014
- Terminated
- December 3, 2014
- Recall Number
- Z-0022-2015
- Quantity
- one system
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Distribution
US distribution to FL
Lot / Code Info
Model Number: Integris Allura 15-12 Serial Number: 16741023
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.