Health product recall

Somatom Definition Edge System CT System & Somatom Drive (2020-11-13)

Starting date:
November 13, 2020
Posting date:
November 27, 2020
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-74429



Last updated:
2020-11-27

Affected Products

A. SOMATOM DEFINITION EDGE SYSTEM CT SYSTEM

B. Somatom Drive

Reason

Siemens has initiated a Customer Safety Advisory SOMATOM Force, SOMATOM Definition as, SOMATOM Definition Edge, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Confidence and SOMATOM Edge Plus with Software syngo CT VB20 or syngo CT VB10. Under special circumstances (e.g. high data volume at 3D interventional workflow) the software VB10 and VB20 may become instable or freezes completely.

Affected products

A. SOMATOM DEFINITION EDGE SYSTEM CT SYSTEM

Lot or serial number

155314

155321

155344

155367

155378

155381

155395

Model or catalog number

10590000

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY


B. Somatom Drive

Lot or serial number

105273

Model or catalog number

10431700

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY