Recall Z-1980-2023 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SenTec AG
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
| Date | Jun 20, 2023 (initiated May 2, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM Sentec, Inc., Aug 9, 2004 |