Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

Recall Insight

This FDA Devices action (record #Z-2252-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on July 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Healthcare Informatics, Inc. is listed as the recalling firm, operating out of Foster City, CA. Federal records indicate 109 units units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.