V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
FDA device recall Z-1980-2023 · posted 2023-06-20 · Open, Classified
Recall details
- Recalling firm
- SenTec AG
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LKD
- Quantity affected
- 11 in the U.S.
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
- Date initiated
- 2023-05-02
- Date posted
- 2023-06-20
- Location
- Therwil, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENTEC DIGITAL MONITOR MODEL #SDM (K041548) | Sentec, Inc. | 2004-08-09 |