Z-0402-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- November 17, 2011
- Termination Date
- November 20, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1330 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
Code Information
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.