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Health product recall

ACUSON SC2000 ULTRASOUND - OPERATING SOFTWARE

Starting date:
May 2, 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, Healthcare Professionals, Hospitals
Identification number:
RA-60370

Affected products

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 resolution region of interest with the trackball.

Affected products

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 Middlefield Road
Mountain View
94043
California
UNITED STATES