Recall Z-1453-06 ยท KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Radiometer America Inc
TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
| Date | Aug 29, 2006 (initiated Apr 7, 2006) |
| Status | Terminated |
| Reason | 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. |
| 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 c |
| Quantity | 61 in U.S. 7 in Canada |
| Distribution | Worldwide-The recalled product was distributed to customers throughout the U.S. and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.