Philips Medical Systems (Cleveland) Inc 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.) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.)
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
serial numbers 4001-4019.
Products Sold
serial numbers 4001-4019.
Philips Medical Systems (Cleveland) Inc is recalling Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 due to The image balance center point correction algorithm used in CT image reconstruction may cause a disapperance or alteration of small circular anatomica. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026