| | Class 2 Recall
Surgical Headlight |  |
| Date Posted |
November 20, 2012 |
| Recall Number |
Z-0402-2013 |
| Product |
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. |
| 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.
|
Recalling Firm/
Manufacturer |
Kerr Corporation
3225 Deming Way
Middleton, Wisconsin 53562 |
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.
|
| Action |
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. |
| Quantity in Commerce |
1330 units |
| Distribution |
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe. |
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