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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Headlight

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 Class 2 Recall
Surgical Headlight
see related information
Date Posted November 20, 2012
Recall Status1 Terminated on November 20, 2012
Recall Number Z-0402-2013
Recall Event ID 63512
Product Classification Light, Surgical Headlight - Product Code EBA
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
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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