V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
FDA Recall Z-1980-2023 · Posted 2023-06-20
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Recalling FirmSenTec AG
Recall StatusOpen, Classified
Product CodeLKD
Date Initiated2023-05-02
Product Quantity11 in the U.S.
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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