FDA Medical Device Recalls (openFDA)
SenTec AG: V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
- Recall number
- Z-1980-2023
- Recalling firm
- SenTec AG
- Product
- V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
- Status
- Open, Classified
- Initiated
- 2023-05-02
- Posted
- 2023-06-20
- Terminated
- not on file
- Reason
- The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
- Root cause
- Device Design
- Action
- The recalling firm issued a recall letter dated 5/2/2023 via email on 5/2/2023. The letter explained the reason for recall also stating that the sensors pose no risk to patients but have a high chance of not functioning upon being connected to an SDM monitor. The recalling firm informed the consignee they want to replace the defective sensors. An RMA was enclosed to return the sensor and the shipping confirmation of its replacement.
- Quantity
- 11 in the U.S.
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
- Lot, serial or model codes
- Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.
- 510(k) numbers
- K041548
- PMA numbers
- not on file
- Product code
- LKD
- Firm FEI
- 3004149774
- Firm city
- Therwil
- Firm state
- not on file
- Firm country
- Switzerland
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