Nov

2015

Siemens MODULARIS VARIOSTAR Cl II

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 11/18/2015
Class lI:

PRODUCT

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Recall Number Z-0265-2016

REASON
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 9/24/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
15

DISTRIBUTION
Distributed in PR and the states of MO, NC, GA, MS, LA, and KY

___________________________________

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 MODULARIS VARIOSTAR Cl II

Amy Sellers

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