Philips Medical Systems Sales & Service Class II

Company: Philips Medical Systems Sales & Service Region No. America
Date of Enforcement Report: 6/2/04
Class: II

PRODUCT
Xcelera System, image processing, radiological. Recall # Z-0973-04.

REASON
Potential for the image data to be erased from the long term archive.

CODE
Part numbers: 9896 050 73251XC1.1L1, Software binder: 9896 050 73252XC1.1L1 Software binder + SP2.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letters on April 15, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
56 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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