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.
Check against the official notice below — it lists the full affected range.
Philips Medical Systems has recalled 22 units of the GEMINI TF 64 Slice CT/PET System due to four software defects in the Tumor LOC software application. These defects may cause the system to irradiate healthy tissue or fail to irradiate diseased tissue during imaging procedures. The affected units are Model #882471 with specific serial numbers ranging from 7007 to 7552 and distributed worldwide across multiple countries including the United States, Canada, Australia, and numerous European and Asian nations.
The record 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: 22 Units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.