11
Mar
2015

Philips Allura Xper X-Ray Angiographic Cl II

0

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 3/11/2015
Class lI:

PRODUCT

Philips Medical System Allura Xper X-Ray Angiographic
Recall Number Z-1120-2015

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

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA 6/6/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7439

DISTRIBUTION
Worldwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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