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Health product recall

ACUSON DIAGNOSTIC ULTRASOUND SYSTEMS (2015-06-30)

Starting date:
June 30, 2015
Posting date:
July 17, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-54260

Affected Products

A.  ACUSON S2000 Diagnostic ultrasound system

B.  ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM

Reason

Potential miscalculation when using the Doppler manual trace measurement tool in a full screen display format. The manual trace tool may incorrectly calculate the time average velocity (tav) and subsequently incorrectly calculate the pulsatility index (pi).

Affected products

A. ACUSON S2000 Diagnostic ultrasound system

Lot or serial number

>10, contact mfg

Model or catalog number

10041461

Companies
Manufacturer
Siemens Medical Solutions USA
Inc.
685 East Middlefield Road
California
UNITED STATES

B.  ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
 

Lot or serial number

>10, contact mfg

Model or catalog number

10441730

Companies
Manufacturer
Siemens Medical Solutions USA
Inc.
685 East Middlefield Road
California
UNITED STATES