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Recall Observatory FDA recall evidence

Device product

Philips Medical System Allura Xper X-Ray Angiographic

Z-1120-2015

June 06, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 70011
Status
Terminated
Classification
Class II
Quantity
7439
Official record key
device-enforcement:Z-1120-2015

Official wording

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

Code information: Software releases: PBL 10, 20, 30, 40, 50, and 60; CV20; R7.2x; R7.6; R8.1; and R8.2.

Distribution pattern: 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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error