Health product recall

MAGNETOM Vida and Sola (2019-06-09)

Starting date:
June 9, 2019
Posting date:
June 21, 2019
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-70263

Last updated: 2019-06-21

Affected Products

A. MAGNETOM Vida
B. MAGNETOM Sola

Reason

The software update to Numaris/ x VA11B provides an extension of the application portfolio for vida systems and resolves the following issues and prevents them from recurring. The update is not providing new features or new functionality. These fixes do not affect patient safety.

  • Stability issues and editing of spine labels automatically generated by the dot engine.
  • Dicom configuration and MR View&Go; 3-D loading within the dot cockpit.
  • Image quality issues with abdomen/liver scans when using grasp vibe, starvibe, multi-breath hold and parallel saturation bands.

Affected products

A. MAGNETOM Vida

Lot or serial number

175628
175645
175658
175664
175677
175726
175759
175821
175842

Model or catalog number

11060815

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

B. MAGNETOM Sola

Lot or serial number

182666
182681
182686

Model or catalog number

11291455

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY