Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System .
Recall
- Recall Number
- Z-1824-2008
- Event Number
- 47834
- Firm
- Resonance Technology Inc
- FEI Number
- 1000306474
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 14, 2007
- Posted
- September 2, 2008
- Terminated
- July 7, 2011
- Address
- 18121 Parthenia St, Northridge, CA, 91325-3350
Description
Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System .
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.
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 [email protected]
Nationwide and Internationally: Canada, Japan, Taiwan, United Kingdom, Netherlands, Italy, Spain, Germany, Switzerland, France,
29 units