10

Nov

2008

Cl Il iSite PACS Software

0

Company: Philips Healthcare Informatics, Inc.,
Date of Enforcement Report 11/5/2008
Class:ll

PRODUCT
iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals, Recall # Z-0118-2009

REASON
Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are both present and different.

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

VOLUME OF PRODUCT IN COMMERCE
27 units

DISTRIBUTION
Nationwide, Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia

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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