Events

Recall of MODULARIS VARIOSTAR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72406
  • Event Risk Class
    Class 2
  • Event Number
    Z-0265-2016
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140957
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lithotriptor, extracorporeal shock-wave,urological - Product Code LNS
  • 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.
  • Action
    Siemens sent a Field Safety Notice (XP044/15/S) dated September 24, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Device

MODULARIS VARIOSTAR
  • Model / Serial
    model# 1157200
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.
  • Product Description
    MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA