Health product recall

SOMATOM Definition AS and Flash (2019-07-18)

Starting date:
July 18, 2019
Posting date:
July 26, 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-70539

Last updated: 2019-07-26

Affected Products

  1. SOMATOM Definition AS
  2. SOMATOM Definition Flash

Reason

Sporadic performance problems with the current software version VA48A-SP5 may result in scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or necessity for patient rescan may occur due to these issues. There are no workarounds available for the identified issues; however, siemens has developed software update CT VA48A-SP6 that includes workflow improvements and bug fixes (firmware & software) for stability and dose report issues observed in the installed base.

Affected products

A. SOMATOM Definition AS

Lot or serial number

65058
92302

Model or catalog number

8098027

Companies
Manufacturer
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY

B. SOMATOM Definition Flash

Lot or serial number

73426
74551

Model or catalog number

10430603

Companies
Manufacturer
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY