Jul

2002

Siemens Medical Systems Class II

Company: Semens Medical Systems
Date of Enforcement Report: 7/31/02
Class: II

PRODUCT
SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology.
Recall # Z-1162-2.

REASON
Software anomalies that affect measurement and calculation data.

CODE
Units with software version 1.0 or 1.1.

RECALLING FIRM/MANUFACTURER
Siemens Medical Systems, Inc., Issaquah, WA, by letter dated January 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
260 units.

DISTRIBUTION
Nationwide.

About the author

Amy Sellers

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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Siemens Medical Systems Class II

Amy Sellers

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