Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.
FDA Recall Z-2346-2008 · Posted 2008-09-18
Recalling FirmPhilips Healthcare Informatics, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-07-03
Date Terminated2009-10-07
Product Quantity198 systems
Reason for Recall
Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
Firm Action
A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.
Root Cause
Software design
Distribution Pattern
Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria
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.