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Health product recall

Acuson S2000 and Acuson S3000 Ultrasound System (2014-05-20)

Starting date:
May 20, 2014
Posting date:
June 5, 2014
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-39879

Recalled Products

a) Acuson S2000 Ultrasound System
b) Acuson S3000 Ultrasound System

Reason

Customers are advised that when using the 9L4 transducer in combination with virtual touch quantification, the displayed mechanical index (MI) may be outside the stated tolerance of plus or minus 15%. This occurs only between the depths of 2.5cm and 3.4cm.

Affected products

a) Acuson S2000 Ultrasound System
 

Lot or serial number

201113
203519
206341
206865
207355
208115
 

Model or catalog number

10041461
 

Companies
Manufacturer
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View
94043
California
UNITED STATES

b) Acuson S3000 Ultrasound System

Lot or serial number

210225
210380
 

Model or catalog number

10441730

Companies
Manufacturer
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View
94043
California
UNITED STATES