—#41582

Product

Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K042935
Affected lot / code info: serial numbers 4001-4019.

Why it was recalled

The image balance center point correction algorithm used in CT image reconstruction may cause a disapperance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. This artifact may lead to the misinterpretation of anatomy at the center of the image.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.

Recalling firm

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

Distribution

Distribution pattern: The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.

Timeline

Recall initiated: 2005-08-18
Posted by FDA: 2005-10-21
Terminated: 2008-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41582. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.