Siemens Medical Solutions USA, Inc recalls MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
- Recall date
- September 24, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0265-2016
- FDA classification
- Class II
- Brand / firm
- Siemens Medical Solutions USA, Inc
- Sold / distributed
- Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
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