Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 11/18/2015
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Recall Number Z-0265-2016
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Siemens Medical Solutions USA, Inc, Malvern, PA on 9/24/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Distributed in PR and the states of MO, NC, GA, MS, LA, and KY