Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
FDA Recall Z-2252-2014 · Posted 2014-08-16
Recalling FirmPhilips Healthcare Informatics, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-07-24
Date Terminated2016-02-11
Product Quantity109 units
Reason for Recall
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.
Firm Action
Urgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail.
Root Cause
Software design
Distribution Pattern
US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.