Inc Class II Siemans Medical Solutions USA

Company: Siemans Medical Solutions USA, Inc
Date of Enforcement Report: 7/23/03
Class: II

PRODUCT
Acuson Cypress Echocardiography System, Imaging System. Catalog # 8264604. Recall # Z-0975-03.

REASON
Software problem – loss of data.

CODE
Serial numbers 70000 through 72000.

RECALLING FIRM/MANUFACTURER
Siemans Medical Solutions USA, Inc., Plymouth Meeting, PA, by letter dated April, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,540 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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Or just email training@softwarecpr.com for more info.

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