—#39752

Product

Gemini 16 PET/CT sytem, Slice Configuration

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K032036
Affected lot / code info: All codes.

Why it was recalled

When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.

Root cause (FDA determination)

Other

Action the firm took

The firm sent recall/field correction letters dated 3/11/05.

Recalling firm

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

Distribution

Distribution pattern: The devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, England, Finland, France, Greece, Germany, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Libya, Mexico, Morocco, Netherlands, New South Wales, New Zealand, Norway, Panama, Phillipines, Portugal, Poland, Romania, Russia, South Africa, Singapore, Slovenia, Spain, Sri Lanka, Switzerland, Sweden, Taiwan, Thailand, Turkey and Venezuela.

Timeline

Recall initiated: 2005-03-11
Posted by FDA: 2005-08-30
Terminated: 2012-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39752. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.