Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
This recall has been terminated (originally issued November 7, 2014).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- July 8, 2014
- Posted
- November 7, 2014
- Terminated
- January 18, 2017
- Recall Number
- Z-0182-2015
- Quantity
- 2 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Distribution
Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
Lot / Code Info
Allura Xper Software version R8.2.0
Root Cause
Software design
Action Taken
Philips Medical Systems issued certified letters on 7/8/14 and receipt returned for tracking purposes. A mandatory Field Change Order with reference FC072200253 is being released that requires Philips field service engineers to install Software release R8.2.0.3. If you need any further information or support concerning this issue, contact your local Philips representative: SUPPORT 1-800-722-9377.