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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