• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM Headset
see related information
Date Posted September 02, 2008
Recall Status1 Open
Recall Number Z-1823-2008
Recall Event ID 47834
Premarket Notification
510(K) Number
K994351 
Product Classification System, Nuclear Magnetic Resonance Imaging - 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, California 91325-3350
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = RESONANCE TECHNOLOGY, INC.
-
-