Apr

2018

Siemens ACUSON SC2000 Cl II

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/4/2018
Class lI:

PRODUCT

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Recall Number Z-1200-2018

REASON
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA on 3/5/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
229 systems

DISTRIBUTION
Nationwide and Internationally

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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 ACUSON SC2000 Cl II

Amy Sellers

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