Philips Electronics North America Corporation recalls Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnos…

Recall date

December 1, 2016

Source

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

Recall number

Z-0924-2017

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

US: WA OUS: China, Spain, Korea, Republic of, Germany

Why it was recalled

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

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

What was recalled

Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).