Health product recall

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

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

Biograph mMR System

Lot or serial number
  • 151014
  • 51018
  • 51068
Model or catalog number
  • 10433372
Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY