—#128568

Product

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033737
Affected lot / code info: Allura Xper Software version R8.2.0

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2014-07-08
Posted by FDA: 2014-11-07
Terminated: 2017-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128568. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.