Home › Device types › LKD
Monitor, Carbon-Dioxide, Cutaneous
FDA product code LKD · Class 2 · Anesthesiology
120
Registered devices
79
Adverse events
23
Recalls
17
510(k) clearances
Devices with this code
TC sensor, Fixation kit — Radiometer Medical ApSContact Gel — SenTec AGPSG Cable C — SenTec AGPSG Cable L — SenTec AGTOSCA-PC interface cable — Radiometer Basel AGPSG-X — SenTec AGTOSCA 500 Cable — Radiometer Basel AGTCM4 combi module, TCpO2/O2 combi module — Radiometer Medical ApSPSG Cable E — SenTec AGPSG Cable K — SenTec AGSechrist Industries, Inc. — SECHRIST INDUSTRIES, INC.Neonatal Starter Set (without Service Gas) — SenTec AGtc Sensor 54 — Radiometer Medical ApSPSG Cable D — SenTec AGTOSCA Open end interface cable 1V FS — Radiometer Basel AGTC pO2/pCO2 electrode — Radiometer Medical ApSV-STATS™ Installation CD — SenTec AG103422 Sensor Adapter Cable (Extra Long) — SenTec AGCOMBI *M sensor 82 — Radiometer Basel AGMulti-Site Attachment Ring for mature/intact skin — SenTec AGFixation Kit For TC electrodes — Radiometer Medical ApSPSG Cable J — SenTec AGTCM4x Cable — Radiometer Medical ApSEar Clip — SenTec AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-25 | SenTec AG | During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on |
| 2023-05-02 | SenTec AG | 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 "releas |
| 2022-08-22 | SenTec AG | Weak skin adhesion. |
| 2020-12-10 | SenTec AG | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. |
| 2020-02-20 | Radiometer Medical ApS | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in dela |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
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