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PIEZOLITH

Richard Wolf GmbH · Model 3000012 · UDI-DI 04055207012437

LNS

510(k) clearances

811

Adverse events (30 deaths)

Recalls

Facilities

Description

LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyces) and in the upper, middle and lower ureter, for extracorporal shock wave lithotripsy, with articulated arm, total energy (12mm) 123mJ, peak pressure (p+) 8 - 126MPa, penetration max. 165mm, focal length F1/F2/F3 (X/YxZ): F1 3,7x30/F2 4,8x32/F3 8,7x63mm, U: 110-120VAC, 50/60Hz, Dim wxhxd 1000x700x1200mm

Recalls

Date	Firm	Reason
2015-09-24	Siemens Medical Solutions USA, Inc	Display 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.