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U.S. Department of Health and Human Services

Class 2 Device Recall M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM Headset

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  Class 2 Device Recall M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM Headset see related information
Date Initiated by Firm May 14, 2007
Date Posted September 02, 2008
Recall Status1 Terminated 3 on July 07, 2011
Recall Number Z-1823-2008
Recall Event ID 47834
510(K)Number K994351  
Product Classification Nuclear magnetic resonance imaging system - Product Code LNH
Product Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.
Code Information Model Number: RTC-2K; Serial No: a) 124-09606 b) 064-10057 c) 064-09863 d) 064-10066 e) 064-09801 f) 064-10055 g) 064-10268 h) 064-09932 i) 124-09624 j) 064-09768 k) 064-09988 l) 064-10226 m) 064-09971 n) 064-09793 o) 064-09837 p) 104-09763 q) 064-10050 r) 124-10193 s) 064-10059 t) 064-10034
Recalling Firm/
Manufacturer		 Resonance Technology Inc
18121 Parthenia St
Northridge CA 91325-3350
For Additional Information Contact
818-882-1997
Manufacturer Reason
for Recall		 Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.
FDA Determined
Cause 2		 Device Design
Action The strategy was notifying customers by written communication. The letter advises Resonance Technology, Inc. is voluntarily recalling the MRI Headset, Model No. RTC-2K and RTC- 551-070 because of potential safety concerns. Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to skin. The letter also advises that Resonance Technology Inc. has designed and developed the significantly improved MRI Headset, Model No. RTC-661-060-09P-001 (upgrade) and began shipping this product in January 2007. Customers who received the Headset Model; RTC-2K and RTC- 551-070, are asked to upgrade to MRI Headset Model No. RTC-661-060-09P-001. Response is requested as to the number of headsets to be replaced. In addition, consignees are advised that if they further distributed this product, to identify their customers and notify them at once of this product recall. If you have questions, contact Olivia Shayesteh at 818-882-1997 or via email at Olivia@mrivideo.com
Quantity in Commerce 20 units
Distribution Nationwide and Internationally: Canada, Japan, Taiwan, United Kingdom, Netherlands, Italy, Spain, Germany, Switzerland, France,
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 = LNH and Original Applicant = RESONANCE TECHNOLOGY, INC.
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