Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.
FDA Recall Z-1443-2008 · Posted 2008-08-16
Recalling FirmPhilips Healthcare Informatics, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-01-29
Date Terminated2008-09-25
Product Quantity3 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
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.