—#140957

Product

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

FDA product code: LNS — Lithotriptor, Extracorporeal Shock-Wave, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070799
Affected lot / code info: model# 1157200

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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

Timeline

Recall initiated: 2015-09-24
Terminated: 2016-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140957. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.