Health product recall

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

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

ACUSON SC2000

Lot or serial number
  • VB20
  • VB21
Model or catalog number

10433816

Companies
Manufacturer

Siemens Medical Solutions USA Inc.

685 East Middlefield Road

Mountain View

94043

California

UNITED STATES