Company: Philips Healthcare Informatics, Inc.
Date of Enforcement Report 8/27/2014
Class lI:
PRODUCT
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Recall Number Z-2252-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA on 7/24/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
109 Units
DISTRIBUTION
Nationwide and Internationally
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