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U.S. Department of Health and Human Services

Class 3 Device Recall CIVCO MTAPSID2932 TypeS Thermoplastic

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  Class 3 Device Recall CIVCO MTAPSID2932 TypeS Thermoplastic see related information
Date Initiated by Firm August 31, 2009
Date Posted November 06, 2009
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-0124-2010
Recall Event ID 53142
510(K)Number K933227  
Product Classification Medical Accelerator Linear - Product Code IYE
Product CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA.

Intended to be used for patient fixation.
Code Information Lot M121560
Recalling Firm/
Manufacturer		 Med Tec Inc
1401 8th St
PO Box 320
Orange City IA 51041-0320
For Additional Information Contact Jenny Jones
712-737-8688
Manufacturer Reason
for Recall		 Some of the packages contain the incorrect mask style.
FDA Determined
Cause 2		 Process control
Action The recalling firm initiated their recall via letter dated 8/27/09 issued certified mail for the domestic customers and e-mail for the foreign customer. The communication informs the customer of the reason for recall and offers to replace the product. For questions or for return of the mask, a phone number is provided. A response form was enclosed with the letter for completion to indicate the amount of affected product in the possession of the customer and whether or not they plan to return it.
Quantity in Commerce 12 boxes
Distribution Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MEDTEC, INC.
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