14
May
2008

Philips iSite PACS Cl II

0

Company: Philips Healthcare Informatics, Inc.,
Date of Enforcement Report 5/14/2008
Class:lll

PRODUCT
iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Recall # Z-1141-2008

REASON
Incorrect display of one of the patient’s images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter on January 21, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
196 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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