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Health product recall

ACUSON SC2000 ULTRASOUND SYSTEM - MAINFRAME (2015-08-20)

Starting date:
August 20, 2015
Posting date:
September 8, 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-54932

Affected Products

A. ACUSON SC2000 ULTRASOUND SYSTEM - MAINFRAME

Reason

The Acuson SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. The system recalls the case sensitivity even if the original study has been removed from the hard drive. if these differences are not corrected at the time of registration, the system does not capture images or clips.
 

Affected products

A. ACUSON SC2000 ULTRASOUND SYSTEM - MAINFRAME
 

Lot or serial number

400319, 401223
401499
401794, 400111
401822
401876
401896

Model or catalog number

10433816

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