MODULARIS VARIOSTAR — Class II medical device recall Z-0265-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-11-18, distributed in GA, KY, LA, MO, MS, NC, PR. Display freeze of MODULARIS hand control results in information not being updated on the display. Current trea
| Recall number | Z-0265-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-09-24 |
| Classified | 2015-11-12 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-12-05 |
| Distributed | GA, KY, LA, MO, MS, NC, PR |
| Quantity | 15 |
| Model numbers | 1157200 |
Product
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0265-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.