Recall Z-0265-2016 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Siemens Medical Solutions USA, Inc
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
| Date | Sep 24, 2015 |
| Status | Terminated |
| Reason | Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. |
| Root cause | Software design |
| Action | Siemens sent a Field Safety Notice (XP044/15/S) dated September 24, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. |
| Quantity | 15 |
| Distribution | Distributed in PR and the states of MO, NC, GA, MS, LA, and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070799 | MODULARIS VARIOSTAR Siemens Medical Solutions USA, Inc., Nov 1, 2007 |