ACUSON SC2000 (2019-10-31)

Starting date:

October 31, 2019

Posting date:

November 22, 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-71672

Last updated: 2019-11-22

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  Reason
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  Affected products

Affected Products

ACUSON SC2000

Reason

Siemens is notifying customers of a variation in the results associated with the eSie Flow SW license on the ACUSON SC2000 ultrasound system. The eSie Flow quantification results are calculated assuming a 0° Angle for all angles of acquisition, however, in software versions VB20 or VB21 the eSie Flow does not correct for the angle of the blood flow. There is an improbable probability that stroke volume, regurgitant volume and regurgitant fraction results will be estimated incorrectly under certain conditions, which may lead to potential patient misdiagnosis

Affected products