LNSClass II

Lithotriptor, Extracorporeal Shock-wave, Urological

Gastroenterology, Urology · 21 CFR 876.5990

MDR events811All time

Recalls1All time

Registered firms47Currently listed

510(k) clearances56All time

Recent MDR events

811 adverse event reports on file

Event type breakdown

Injury569

Malfunction171

Other32

Death30

Unspecified9

Most-reported manufacturers

Dornier Medtech Systems Gmbh411 Storz Medical Ag88 Healthtronics, Inc.62 Dornier Medtech Gmbh49 Unspecified19 Dornier Medtech America, Inc.16 Dornier Medtech Systems, Gmbh16 Dornier Medizintechnik Gmbh14

Recalls

1 recall events for this product code

Siemens Medical Solutions USA, Inc
TerminatedUnknown
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Z-0265-2016 · View FDA record ↗

Registered firms

47 firms currently registered for this product code

510(k) clearances

56 clearances for this product code