Health product recall

SOMATOM Definition AS, Definition Edge, Drive, Confidence (2021-04-15)

Starting date:
April 15, 2021
Posting date:
May 6, 2021
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-75525



Last updated:
2021-05-06

Affected Products 

A. SOMATOM DEFINITION AS - MAIN UNIT

B. SOMATOM DEFINITION EDGE SYSTEM - CT SYSTEM

C. SOMATOM DRIVE

D. SOMATOM CONFIDENCE - SYSTEM

Reason

Siemens Healthcareis notifying customers with affected SOMATOM systemsrunningsoftware versionsyngo.CT VB10Aofa software update to version VB10A_SP3. The software update will solve sporadicproblems that may result in scanning workflow interruptions.

Affected products

A. SOMATOM DEFINITION AS - MAIN UNIT

Lot or serial number

95810

Model or catalog number

8098027

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY


B. SOMATOM DEFINITION EDGE SYSTEM - CT SYSTEM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

10590000

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY


C. SOMATOM DRIVE

Lot or serial number

105273

Model or catalog number

10431700

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY


D. SOMATOM CONFIDENCE - SYSTEM

Lot or serial number

100384

Model or catalog number

10590100

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY