Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. 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.
FDA Recall Z-0181-2015 · Posted 2014-11-07
Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeOWB
Date Initiated2014-07-08
Date Terminated2017-01-18
Product Quantity22 systems
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.