Device product

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

Z-0265-2016

September 24, 2015

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 72406
Status: Terminated
Classification: Class II
Quantity: 15
Official record key: device-enforcement:Z-0265-2016

Official wording

Reason: Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

Code information: model# 1157200

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.