Class 2 Device Recall MODULARIS VARIOSTAR

• Date Initiated by Firm: September 24, 2015
• Create Date: November 12, 2015
• Recall Status: Terminated on December 05, 2016
• Recall Number: Z-0265-2016
• Recall Event ID: 72406
• 510(K)Number: K070799
• Product Classification: Lithotriptor, extracorporeal shock-wave,urological - Product Code LNS
• Product: MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
• Code Information: model# 1157200
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: 610-219-6300
• Manufacturer Reason for Recall: Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 15
• Distribution: Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LNS