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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