Medical device recalls Moderate risk

Philips Medical Systems, Inc. recalls Philips Medical System Allura Xper X-Ray Angiographic

Recall date
June 6, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1120-2015
FDA classification
Class II
Brand / firm
Philips Medical Systems, Inc.
Sold / distributed
Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada, China, Croatia, Czech Republic, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, P…

Why it was recalled

In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

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 Medical System Allura Xper X-Ray Angiographic

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