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U.S. Department of Health and Human Services

Class 3 Device Recall TCm monitoring system

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 Class 3 Device Recall TCm monitoring systemsee related information
Date Initiated by FirmApril 07, 2006
Date PostedAugust 29, 2006
Recall Status1 Terminated 3 on April 25, 2012
Recall NumberZ-1453-06
Recall Event ID 35696
Product Classification Monitoring system - Product Code KLK
ProductTCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
Code Information TCM4 - Base Unit : Model: 391-876, Lot Numbrs R0036 thru R0043 (both inclusive). CompactFlash cards - Component: Model #914-698
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact
440-871-8900
Manufacturer 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 Determined
Cause 2		Other
ActionThe 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 Commerce61 in U.S. 7 in Canada
DistributionWorldwide-The recalled product was distributed to customers throughout the U.S. and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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