Philips Healthcare Informatics, Inc. Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.
Brand
Philips Healthcare Informatics, Inc.
Lot Codes / Batch Numbers
Version number 3.6.28.0
Products Sold
Version number 3.6.28.0
Philips Healthcare Informatics, Inc. is recalling Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - due to When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a de. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool.
Recommended Action
Per FDA guidance
The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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Page updated: Jan 10, 2026