Z-0341-2012

TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003

Name: Z-0341-2012 TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003
Creator: Radiometer America Inc
Published: 2011-09-27
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2011-09-27 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of 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... on 2011-09-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0341-2012
Status: Terminated
Initiated: 2011-09-27
Posted: 2011-12-01
Terminated: 2012-02-19
Recalling firm: Radiometer America, Inc
Product: 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).
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 4 units were distributed.
Distribution: Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.
Product codes and lots: Part Number: 945-655, Lot Code: DP-06

Product code LKD

K043003Class IITcm40 Monitoring SystemRadiometer Medical Aps / cleared 2005-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)