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