Resonance Technology Inc Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.
Brand
Resonance Technology Inc
Lot Codes / Batch Numbers
Model Number: RTC-2K
Products Sold
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
Resonance Technology Inc is recalling Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stere due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026