FDA-Device2015-11-18Class II
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Siemens Medical Solutions USA, Inc
Hazard
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Sold states
Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.
Affected count
15
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0265-2016Don't want to check this manually?
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