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U.S. Department of Health and Human Services

Class 2 Device Recall MODULARIS VARIOSTAR

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  Class 2 Device Recall MODULARIS VARIOSTAR see related information
Date Initiated by Firm September 24, 2015
Create Date November 12, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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