Product Wiki · Recalls · Health Canada — Medical Devices

Biograph mMR System (2018-10-14) — recall 58411

Health Canada — Medical Devices · Canada · 2018-10-26 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58411
Date of alert
2018-10-26
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens is informing Biograph mMR users of a potential performance issue with the BodyCOMPASS functionality for pet motion compensation. The issue occurs when BodyCOMPASS is used for elastic motion correction (BodyCOMPASS is an option for syngo E11p). Due to an issue with the resampling of the motion vectors, the BodyCOMPASS does not work for patient orientations other than Head First Supine (HFS). Furthermore, also in HFS patient orientation the motion correction is not working efficiently. As a result the pet motion correction when using BodyCOMPASS delivers suboptimal results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/biograph-mmr-system-2018-10-14

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