FDA Medical Device Recalls (openFDA)
Resonance Technology Inc: Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.
- Recall number
- Z-1823-2008
- Recalling firm
- Resonance Technology Inc
- Product
- Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.
- Status
- Terminated
- Initiated
- 2007-05-14
- Posted
- 2008-09-02
- Terminated
- 2011-07-07
- Reason
- 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.
- Root cause
- 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
- 20 units
- Distribution
- Nationwide and Internationally: Canada, Japan, Taiwan, United Kingdom, Netherlands, Italy, Spain, Germany, Switzerland, France,
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K994351"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1000306474
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28