—#34642

Product

Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009
Affected lot / code info: All serial numbers. Software version 1.0 or 1.0.1

Why it was recalled

Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.

Root cause (FDA determination)

Other

Action the firm took

Revised, corrected software has been shipped to consignees beginning June, 2004.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: The systems were installed at medical facilities located nationwide and worldwide.

Timeline

Recall initiated: 2004-08-02
Posted by FDA: 2006-05-19
Terminated: 2012-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.