—#66521

Product

Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Philips Medical Systems, Cleveland, OH 44143

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051170, K052640
Affected lot / code info: Gemini GXL Product Numbers/Manufacturer Numbers: GXL 16 slice: 4535 679 71891, GXL 10 slice: 4535 679 75681, GXL 6 slice: 4535 679 75691. Catalog Numbers: GXL 16 slice: 882410, GXL 10 slice: 882400, GXL 6 slice: 882390. Serial Numbers: 4034-4159.

Why it was recalled

Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical notified domestic customers via Product Safety Notification dated May 30, 2007. The product safety notification includes a Technical Bulletin notifying customers of the issue and how to avoid it. This information will be used until the software correction becomes available. The software correction will be released in October 2008. Once software is available, the firm will begin correcting the field.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA, Australia, Belgium, Canada, China, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Netherlands, Poland, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Taiwan, Turkey, and Venezuela.

Timeline

Recall initiated: 2007-09-21
Posted by FDA: 2008-01-31
Terminated: 2012-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.