Z-0265-2016Class II

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis

Name: Z-0265-2016 MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-09-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-09-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis on 2015-09-24. FDA classified it as Class II and gives the reason as "Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0265-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-24
Posted: 2015-11-12
Terminated: 2016-12-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Product code: LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
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.
Root cause tag: software
FDA root 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.
Product codes and lots: model# 1157200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0265-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12

Product code LNS

K070799Class IIModularis VariostarSiemens Medical Solutions USA, Inc. / cleared 2007-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)