Somatom Definition AS - Main Unit and Somatom Definition Edge System - CT System (2019-09-05)

Starting date:

September 5, 2019

Posting date:

October 11, 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-71225

Last updated: 2019-10-11

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  Reason
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  Affected products

Affected Products

A. Somatom Definition AS - Main Unit

B. Somatom Definition Edge System - CT System

Reason

Sporadic performance problems with the current software version VA44A_SP6 may result in scanning workflow interruptions. 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 VA44A_SP7 that includes workflow improvements and bug fixes (firmware software) for stability issues observed in the installed base.

Affected products