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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