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 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.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.