FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Sensis Vibe System, Model Number 11007642, with software version VD10B.
- Recall number
- Z-0936-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Sensis Vibe System, Model Number 11007642, with software version VD10B.
- Status
- Terminated
- Initiated
- 2018-11-29
- Posted
- not on file
- Terminated
- 2020-05-07
- Reason
- A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
- Root cause
- Software design
- Action
- Urgent Medical Device Correction letters were sent to customers on 11/29/18.
- Quantity
- 1
- Distribution
- The products were distributed to the following US states: NJ.
- Lot, serial or model codes
- Serial Number 120019
- 510(k) numbers
- ["K150493"]
- PMA numbers
- not on file
- Product code
- DQK
- 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