Z-0068-06

Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice...

Name: Z-0068-06 Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2005-08-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-08-18 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2005-08-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0068-06
Status: Terminated
Initiated: 2005-08-18
Posted: 2005-10-21
Terminated: 2008-10-29
Recalling firm: Philips North America LLC
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.)
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.
Quantity in commerce: 19 devices
Distribution: The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.
Product codes and lots: serial numbers 4001-4019.

Product code JAK

K042935Class IIGemini GxlPhilips Medical Systems (Cleveland), Inc. / cleared 2004-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)