18

Feb

2009

Cl Il iSite PACS

0

Company:Philips Healthcare Informatics, Inc
Date of Enforcement Report 2/18/2009
Class:ll

PRODUCT
iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Recall # Z-0948-2009

REASON
Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City , CA , by letter on December 29, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
40 units

DISTRIBUTION
Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, Brazil

About the author

Amy Sellers

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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