Product Wiki · Recalls · Health Canada — Medical Devices

Discovery PET/CT 710 System (2013-11-22) — recall 50941

Health Canada — Medical Devices · Canada · 2014-01-06 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
50941
Date of alert
2014-01-06
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: A software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and over-correction. Reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. This issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions. This defect may lead to misinterpretation of the image and/or inaccurate treatment decisions.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/discovery-petct-710-system-201

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