Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. |
| Quantity | 15 |
| Distribution | Distributed in PR and the states of MO, NC, GA, MS, LA, and KY. |
| Initiated | 2015-09-24 |
| Classified | 2015-11-12 |
| Terminated | 2016-12-05 |
| Recall number | Z-0265-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-0265-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72406/
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