22
Feb
2008

Philips Medical Systems Image Viewer Class II

0

Company:Philips Medical Systems
Date of Enforcement Report 2/20/2008
Class:ll

PRODUCT
Philips Medical Systems — Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5, Recall Z-0676-2008

REASON
Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed and saved in a batch file..

RECALLING FIRM/MANUFACTURER
Phillips Nuclear Medicine, Milpitas, CA, by letter on September 28, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
19 units

DISTRIBUTION
Nationwide and Internationally

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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