Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
This recall has been terminated (originally issued April 25, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- April 2, 2012
- Posted
- April 25, 2012
- Terminated
- May 9, 2014
- Recall Number
- Z-1462-2012
- Quantity
- 145
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The monitor Ceiling suspension may fail, which may cause the monitor to drop.
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Belgium, Brazil, Canada, Czech Rep, Chili, China, Columbia, Denmark, Egypt, France, Germany, India, Indonesia, Italy, Japan, Malaysia, Mexico, Morocco, Netherlands, Oman, Russia, Saudi Arabia, Singapore, South Korea, Spain, Thailand, United Kingdom, and Vietnam.
Lot / Code Info
722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722001, 722003, 722008
Root Cause
Process control
Action Taken
Philips sent an "URGENT-FIELD SAFETY NOTICE" dated March 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides information for continued safe and proper use of the equipment. Contact your local Philips representative at 866-767-2822 for further support regarding this issue. Recall expanded 5-2013 to additional 460 units distributed worldwide.