FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer
- Recall number
- Z-2688-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
- Status
- Terminated
- Initiated
- 2017-05-16
- Posted
- not on file
- Terminated
- 2018-08-22
- Reason
- Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.
- Root cause
- Software design
- Action
- Siemens sent an Customer Safety Advisory Notice dated May 16, 2017, was mailed to all users on May 16, 2017. The letter informs customers of the software issue and potential impact. Siemens Medical Solutions will contact users to make arrangements to update the system with updated software to correct the issue. For further questions, please call (610) 448-6461.
- Quantity
- US: 13 units
- Distribution
- US Distribution to the states of : IN, MI, IA
- Lot, serial or model codes
- Software Version VD10B
- 510(k) numbers
- ["K020440"]
- 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