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ACUSON SC2000 ULTRASOUND - OPERATING SOFTWARE (2016-05-02)
- Starting date:
- May 2, 2016
- Posting date:
- May 16, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-58400
Affected products
- ACUSON SC2000 ULTRASOUND - OPERATING SOFTWARE
Reason
While imaging with a transesophageal (TEE) transducer (z6ms, v5ms, or v7m), the operator may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-Mode cursor, the 2D field of view, or the res region of interest with the trackball.
Affected products
A. ACUSON SC2000 ULTRASOUND - OPERATING SOFTWARE
Lot or serial number
- 402544
- 402618
Model or catalog number
- 4.0
Companies
- Manufacturer
-
Siemens Medical Solutions USA
Inc.
685 East Middlefield Road
California
UNITED STATES