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 Recall Z-0462-2008 · Posted 2008-01-31
Advertisement
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2007-09-21
Date Terminated2012-03-02
Product Quantity126
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
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.
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.
Advertisement