Biograph mMR System (2018-10-14)

Starting date:

October 14, 2018

Posting date:

October 26, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68098

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  Reason
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  Affected products

Affected products

Biograph mMR System

Reason

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.

Affected products