GEMINI LXL 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 (Cleveland) Inc. has recalled the GEMINI LXL CT/PET imaging system due to four software defects in the Tumor LOC software application. These defects may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue during diagnostic imaging procedures. The recall affects two units worldwide: Model #882412 GEMINI LXL with Serial Numbers 14702 and 14707.
The affected systems have been distributed to facilities in the United States and 19 other countries including Australia, Canada, China, France, Germany, Japan, and others. The source document does not specify a remedy or what actions affected consumers should take regarding 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: 2 units Lot/code info: Model #882412 GEMINI LXL (459800018631); Serial Number: 14702 & 14707.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.