Z-1824-2008

Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo...

Name: Z-1824-2008 Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo...
Creator: Resonance Technology Inc
Published: 2007-05-14
License: https://open.fda.gov/license/

Resonance Technology Inc / initiated 2007-05-14 / Terminated / root cause: design

FDA source

Resonance Technology Inc began a recall of Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System on 2007-05-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1824-2008
Status: Terminated
Initiated: 2007-05-14
Posted: 2008-09-02
Terminated: 2011-07-07
Recalling firm: Resonance Technology Inc
Product: Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System .
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: design
FDA 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 [email protected]
Quantity in commerce: 29 units
Distribution: Nationwide and Internationally: Canada, Japan, Taiwan, United Kingdom, Netherlands, Italy, Spain, Germany, Switzerland, France,
Product codes and lots: Model Number RTC-551-070; Serial No: a) 064-10288 b) 064-10279 c) 114-09556 d) 124-09898 e) 104-09995 f) 064-10220 g) 064-10286 h) 124-09491 i) 104-09828 j) 064-10229 k) 064-10211 l) 064-10241 m) 064-10214 n)064-09983 o) 064-10243 p) 064-10289 q) 064-10207 r) 064-10132 s) 104-09872 t) 064-10221 u) 064-10127 v) 064-10215 w) 104-09966 x) 064-10263 y) 124-10116 z) 124-09983 aa) 124-09600 bb) 114-09613 cc) 064-09479

Product code LNH

K994351Class IIM.r. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. / cleared 2000-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)