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ACUSON ULTRASOUND SYSTEMS (2015-07-02)
- Starting date:
- July 2, 2015
- Posting date:
- July 21, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54312
Affected Products
- ACUSON S2000
- ACUSON S1000
- ACUSON S3000
Reason
To notify users of the ACUSON family ultrasound systems of a recent finding regarding needle guides. Two Transducers, 6C1 HD and 18l6 HD demonstrate misalignment while utilizing the on-screen guidelines.
The issue occurs when using the CIVCO Biopsy attachments in combination with the ACUSON family on-screen guidelines. The biopsy needle may traverse outside the on-screen guidelines. This occurs on the 6c1 HD and 18l6 HD Transducers.
Affected products
A.ACUSON S2000
Lot or serial number
>10 contact manufacturer
Model or catalog number
10041461
Companies
- Manufacturer
-
Siemens Medical Solutions USA
Inc.
685 East Middlefield Road
California
UNITED STATES
B. ACUSON S1000
Lot or serial number
211263
Model or catalog number
10441701
Companies
- Manufacturer
-
Siemens Medical Solutions USA
Inc.
685 East Middlefield Road
California
UNITED STATES
C. ACUSON S3000
Lot or serial number
>10 contact manufacturer
Model or catalog number
10441730
Companies
- Manufacturer
-
Siemens Medical Solutions USA
Inc.
685 East Middlefield Road
California
UNITED STATES