FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
- Recall number
- Z-0265-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
- Status
- Terminated
- Initiated
- 2015-09-24
- Posted
- not on file
- Terminated
- 2016-12-05
- 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.
- Lot, serial or model codes
- model# 1157200
- 510(k) numbers
- ["K070799"]
- PMA numbers
- not on file
- Product code
- LNS
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28