FDA-Device2014-08-27Class II
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Philips Healthcare Informatics, Inc.
Hazard
A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
Sold states
US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Affected count
109 units
Manufactured in
4100 E 3rd Ave Ste 101, Foster City, CA, United States
Products
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2252-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief