Philips Electronics North America Corporation recalls INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic…

Recall date

November 3, 2015

Source

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

Recall number

Z-0729-2016

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Dem…

Why it was recalled

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

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

What was recalled

INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions