FDAFDA · Food and drugs·Recall number Z-0402-2013
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
Published November 28, 2012 · Recall initiated: November 17, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kerr Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
- Lot
- Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System has no expiration date. The affected units were produced and distributed since February 2011.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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