Recall Z-0341-2012 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Radiometer America Inc
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
| Date | Dec 1, 2011 (initiated Sep 27, 2011) |
| Status | Terminated |
| Reason | Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use. |
| Root cause | Employee error |
| Action | Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463. |
| Quantity | 4 units were distributed. |
| Distribution | Worldwide Distribution - USA (nationwide) in the state of San Diego, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043003 | TCM40 MONITORING SYSTEM Radiometer Medical Aps, Mar 1, 2005 |