GEMINI TF 16 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.
Check against the official notice below — it lists the full affected range.
Philips Medical Systems has identified four software defects in the Tumor LOC software application used in the GEMINI TF 16 Slice CT/PET System. These defects may cause healthy tissue to be irradiated or diseased tissue to not be irradiated during imaging procedures. The affected devices are Model #882470 with 13 specific serial numbers (7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226, and 7570) that were distributed worldwide, including throughout the United States, Europe, Asia, and other regions.
The recall record does not specify a remedy or recommended action for consumers or healthcare facilities affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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. Quantity: 13 Units Lot/code info: Model #882470 GEMINI TF 16 Slice (453567983931); Serial Number: 7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226 & 7570.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.