Radiometer America Inc TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.