Z-1437-06

TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)

Name: Z-1437-06 TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)
Creator: Radiometer America Inc
Published: 2005-02-02
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-02-02 / Terminated

FDA source

Radiometer America Inc began a recall of TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor) on 2005-02-02. The reason FDA records is "Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1437-06
Status: Terminated
Initiated: 2005-02-02
Posted: 2006-08-30
Terminated: 2012-05-09
Recalling firm: Radiometer America, Inc
Product: TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)
Product code: KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Reason for recall: Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped.
FDA root cause: Other
Action: The firm initiated a recall action for the suspect device with a letter dated 2/2/2005. During a site visit to the U.S. customers conducted by the firm''s Field Service reps, the reps informed the user/customers of this problem and requested that all use of the device be discontinued, pending the formulation of a more permanent solution. Beginning on 2/8/2005, a second site visit was made to the same user/customers, at which time, the affected units were upgraded with operating software version 2.12. The firm''s recall/corrective action was scheduled for completion by 3/1/2005.
Quantity in commerce: 9 monitors were distributed.
Distribution: Nationwide
Product codes and lots: All Model #TCM4

Product code KLK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)