Philips Electronics North America Corporation recalls Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended…

Recall date

October 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1066-2016

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.