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

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  Reason
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  Affected products

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