Recall Z-1823-2008 ยท LNH System, Nuclear Magnetic Resonance Imaging
Resonance Technology Inc
Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.
| Date | Sep 2, 2008 (initiated May 14, 2007) |
| Status | Terminated |
| 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- |
| Quantity | 20 units |
| Distribution | Nationwide and Internationally: Canada, Japan, Taiwan, United Kingdom, Netherlands, Italy, Spain, Germany, Switzerland, France, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994351 | M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM Resonance Technology, Inc., Mar 22, 2000 |