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Acuson S2000 and 3000 Ultrasound System (2014-05-21)
- Starting date:
- May 21, 2014
- Posting date:
- June 12, 2014
- 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-39991
Recalled products
- Acuson S2000 Ultrasound System
- Acuson 3000 Uultrasound System
Reason
Siemens confirmed that there is a potential measurement error when using the auto-stats (auto statistics) measurement tool on ACUSON S family ultrasound systems with software versions VC25D, VC30A and VC30B. The potential risk to the patient is the measurement and/or calculations will be incorrect and will have to be repeated.
Affected products
A. Acuson S2000 Ultrasound System
Lot or serial number
- 207922
- 210320
Model or catalog number
- 10041461
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View
94043
California
UNITED STATES
B. Acuson 3000 Uultrasound System
Lot or serial number
- 210095
- 210225
- 210380
Model or catalog number
- 10441730
Companies
- Manufacturer
-
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View
94043
California
UNITED STATES