08
Jun
2011

Cl ll ACUSON S2000 ultrasound software

0

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 6/8/2011
Class ll:

PRODUCT
ACUSON S2000 ultrasound system. Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications. Model Number 10041461-ACUSON S2000. Recall # Z-2051-2011

REASON
The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report..

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on March 15, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1533 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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