Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
FDA Recall Z-0889-06 · Posted 2006-05-19
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-08-02
Date Terminated2012-03-02
Product Quantity397 devices.
Reason for Recall
Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
Firm Action
Revised, corrected software has been shipped to consignees beginning June, 2004.
Root Cause
Other
Distribution Pattern
The systems were installed at medical facilities located nationwide and worldwide.
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.