FDA Device recall Z-0265-2016
MODULARIS VARIOSTAR
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of MODULARIS VARIOSTAR by Siemens Medical Solutions Usa, citing display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0265-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-24 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | GA, KY, LA, MO, MS, NC, PR |
Product
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
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.
Identifiers
| code_info | model# 1157200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0265-2016%22
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