Device product
GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Z-2196-2015
Product summary
- Event
- Event 71699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 Units
- Official record key
device-enforcement:Z-2196-2015
Official wording
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
Code information: Model #882471 GEMINI TF 64 Slice (453567994741); Serial Number: 7007, 7012, 7042, 7055, 7083, 7103, 7116, 7126, 7132, 7158, 7160, 7164, 7169, 7175, 7179, 7218, 7221, 7229, 7245, 7255, 7256 & 7552.
Distribution pattern: Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.
Derived failure modes
-
Device software or design
software defects in the Tumor LOC software application that may potentially result in