GEMINI TF Base 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 two GEMINI TF Base CT/PET imaging systems due to four software defects identified in the Tumor LOC software application. These defects may potentially cause healthy tissue to be irradiated or diseased tissue to not receive necessary radiation during treatment planning.
The affected units are Model #882473 with serial numbers 7111 and 7150, and were distributed worldwide including locations in the United States, Australia, Canada, China, Japan, and numerous other countries. The source document does not specify a remedy or recommended action for affected 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: 2 Units Lot/code info: Model #882473 GEMINI TF Base (453567441711); Serial Number: 7111 & 7150.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.