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Somatom Definition AS — recall 59692

Health Canada — Medical Devices · Canada · 2019-10-11 · Type III

As described by Health Canada — Medical Devices: Somatom Definition AS - Main Unit and Somatom Definition Edge System - CT System (2019-09-05)

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Agency
Health Canada — Medical Devices
Recall identifier
59692
Date of alert
2019-10-11
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Sporadic performance problems with the current software version VA44A_SP6 may result in scanning workflow interruptions. Delay in diagnosis or necessity for patient rescan may occur due to these issues. There are no workarounds available for the identified issues. However, Siemens has developed software update CT VA44A_SP7 that includes workflow improvements and bug fixes (firmware software) for stability issues observed in the installed base.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/somatom-definition-main-unit-a

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