Canon Medical System, USA, INC. is recalling 27 Cartesion Prime Digital PET-CT imaging systems (Model PCD-1000A) due to a software defect that can cause the image reconstruction process to fail. If the system is performing reconstruction for one patient while a new scan is started for another patient, the software may hang, potentially causing the loss of diagnostic data. Approximately 27 units are affected, and while no injuries have been reported, this failure may require patients to undergo repeat PET/CT examinations. Healthcare facilities should contact Canon Medical System to arrange for necessary software corrections.
The software failure can cause the imaging system to stop working during data processing, which may lead to the loss of medical images. This necessitates repeat scanning procedures, exposing patients to additional, unnecessary radiation.
Total quantity affected: 27 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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