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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