Biograph MMR System (2018-01-26)

Starting date:

January 26, 2018

Posting date:

March 23, 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-66268

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  Reason
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  Affected products

Affected products

Biograph MMR System

Reason

Siemens has identified a mismatch between orientation labels and displayed anatomy (e.g. in the 3D task card) within the software version syngo MR E11P for Biograph mMR. This will lead to a wrong attenuation correction of the pet data.

Affected products