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Extracorporeal Shock Wave Lithotripter

Suzhou Xixin Medical Instruments Co., Ltd. · Model CS-2012A-3 · UDI-DI 06975438931018

LNS Prescription
1
510(k) clearances
818
Adverse events (30 deaths)
1
Recalls
19
Facilities

Recalls

DateFirmReason
2015-09-24Siemens Medical Solutions USA, IncDisplay freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.