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ACUSON SC2000 (2015-07-30)
- Starting date:
- July 30, 2015
- Posting date:
- August 18, 2015
- 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-54696
Affected Products
A. ACUSON SC2000
Reason
As a result of in-house product testing, it was discovered that when performing a 2D stress echo study, specific keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
The issue is present only for users with software versions VA16A and VA30A. It is solved in customers with software version 3.5 (VA35) or 4.0(VA40).
Affected products
A. ACUSON SC2000
Lot or serial number
- 400111
- 400319
Model or catalog number
10433816
Companies
- Manufacturer
-
Siemens Medical Solutions USA
Inc.
685 East Middlefield Road
California
UNITED STATES