30
Mar
2005

Philips Medical Systems Class Class II

0

Company: Philips Medical Systems Sales and Service Region No. Americ.
Date of Enforcement Report: 3/30/05
Class: II

PRODUCT
Xcelera R1.2. Cardiology image and information management solution software. Recall # Z-0640-05.

REASON
Loss of image data from image repository and archive requiring patients to undergo repeat imaging.

CODE
Xcelera Software version R1.2.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales and Service Region No. America, Bothell, WA, by letter on December 21, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33 units.

DISTRIBUTION
Nationwide.

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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