—#140621

Product

Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141979
Affected lot / code info: Product Codes: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059 systems with release R8.2.16

Why it was recalled

Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.

Root cause (FDA determination)

Software design

Action the firm took

Philips sent a Field Safety Notice to all affected customers on October 1, 2015. The notice informs customers of the issue and the actions planned by Philips. Philips Field Service Engineers are to install Software R8.2.16.1 which addresses the issue. For further information or support concerning the issue, consignees should contact their local Philips Representative or call the Technical Support Line at 800-722-9377.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: US Nationwide in the states of : AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, WV and the country of Canada.

Timeline

Recall initiated: 2015-10-01
Terminated: 2020-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.