device · product 1 of 1
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.
- Recall number
- Z-0402-2013
- Initiated
- November 17, 2011
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Kerr Corporation
- Quantity
- 1330 units
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Labeling mix-ups
Inspect official wording and provenance
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.
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.
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.