Biograph mMR System (2018-04-18)

Starting date:

April 18, 2018

Posting date:

May 4, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66694

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  Reason
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  Affected products

Affected products

Biograph mMR System

Reason

Siemens has identified the potential for a mismatch between PET and MR images in z-direction when viewing fused images on select mMR systems. The issue is visible when users are viewing fused PET and MR images e.g. in the syngo 3D Fusion task card. When PET and MR images are compared thoroughly in an overview layout (side-by-side) e.g. in syngo.via, the effect can be observed, too.


The original MR and the non-attenuation-corrected PET images are presented correctly, but due to a miscalculation the alignment of the fused MR and PET images, both non-attenuation-corrected (NAC) and attenuation-corrected (AC) is not performed as expected. Also due to the same miscalculation, the quality of PET AC images may be degraded slightly.

Affected products