FDA-Device2015-03-11Class II
Philips Medical System Allura Xper X-Ray Angiographic
Philips Medical Systems, Inc.
Hazard
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Sold states
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, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Reunion, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Saudi Arabia, Switzerland, Syria, Taiwan, Thailand, France, Dominican Republic, Colombia, Turkey, Germany, Greece, Hong Kong, Denmark, Ecuador, Egypt, Estonia, Finland, Vietnam, Russian Federation, Iran, Iraq, Ireland, Israel, Italy, India, Indonesia, Japan, Jordan, Kenya, South Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldavia, Mongolia, Morocco, Nepal, Ukraine, United Arab Emirates, and United Kingdom
Affected count
7439
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Medical System Allura Xper X-Ray Angiographic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1120-2015Don't want to check this manually?
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