GEMINI TF Ready 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 recalled one Philips GEMINI TF Ready CT/PET imaging system due to four software defects in the Tumor LOC software application. These defects may potentially cause healthy tissue to be irradiated or diseased tissue to not be irradiated during diagnostic imaging. The affected unit is Model #882473 with Serial Number 7237 (453567441711).
The recalled system was distributed worldwide, including to facilities in the United States, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela, and Vietnam. The source does not specify a remedy or corrective action for consumers.
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: 1 unit Lot/code info: Model #882473 GEMINI TF Ready (453567441711); Serial Number: 7237.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.