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Terminated

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

FDA Recall Z-0265-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNS
Date Initiated2015-09-24
Date Terminated2016-12-05
Product Quantity15

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070799MODULARIS VARIOSTARSiemens Medical Solutions USA, Inc. · 2007-11-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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