Z-1453-06

TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective...

Name: Z-1453-06 TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective...
Creator: Radiometer America Inc
Published: 2006-04-07
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-04-07 / Terminated

FDA source

Radiometer America Inc began a recall of TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component) on 2006-04-07. The reason FDA records is "System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1453-06
Status: Terminated
Initiated: 2006-04-07
Posted: 2006-08-29
Terminated: 2012-04-25
Recalling firm: Radiometer America, Inc
Product: TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
Product code: KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Reason for recall: System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.
FDA root cause: Other
Action: The firm began a recall/corrective action in response to this component defect on 4/7/2006, at which time, the firm issued a Field Action Notes memo (915-234). The firm is having their representatives: 1) assure that the use of the CompactFlashcards manufactured by Simple Tech has been discontinued at each customer location; 2) Replaace the CompactFlash card in all basic Units, 391-876, of R0036 through R0043; and 3) replace any spare part #914-698, which has been installed in Basic Units, 391--876, below R0036. Once completed, the firm has supplied their customers with a TELEFAX form to be completed, signed and dated by each customerand faxed back to Radiometer Medical ApS. The form documents that the instructions provided in theField Action Notes have been followed and that the necessary component replacements have been completed. The firm anticipates that the necesary corrective action will be completed by 7/1/2006.
Quantity in commerce: 61 in U.S. 7 in Canada
Distribution: Worldwide-The recalled product was distributed to customers throughout the U.S. and Canada.
Product codes and lots: TCM4 - Base Unit : Model: 391-876, Lot Numbrs R0036 thru R0043 (both inclusive). CompactFlash cards - Component: Model #914-698

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)