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 Recall Z-0068-06 · Posted 2005-10-21
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2005-08-18
Date Terminated2008-10-29
Product Quantity19 devices
Reason for Recall
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.
Firm Action
The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.
Root Cause
Other
Distribution Pattern
The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.
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.