Drug recall
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
FDA recall event 72406 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 72406 |
|---|---|
| Recall numbers | Z-0265-2016 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. |
| Initiation date | Sep 24, 2015 |
| Report date | Nov 18, 2015 |
| Termination date | Dec 5, 2016 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: