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
- Recall Number
- Z-0402-2013
- Event Number
- 63512
- Firm
- Kerr Corporation
- FEI Number
- 3003848022
- Product Code
- EBA
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- November 17, 2011
- Posted
- November 20, 2012
- Terminated
- November 20, 2012
- Address
- 3225 Deming Way, Middleton, WI, 53562
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.
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.
Orascoptic sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 17, 2011. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return to the firm. Contact Orascoptic Customer Care at 608-831-2555 for assistance regarding this notice.
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
1330 units