Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.

FDA device recall Z-1823-2008 · posted 2008-09-02 · Terminated

Recall details

Recalling firm

Resonance Technology Inc

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.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

LNH

Quantity affected

20 units

Distribution

Nationwide and Internationally: Canada, Japan, Taiwan, United Kingdom, Netherlands, Italy, Spain, Germany, Switzerland, France,

Date initiated

2007-05-14

Date posted

2008-09-02

Date terminated

2011-07-07

Location

Northridge, CA

Related 510(k) clearances