| Class 2 Device Recall Surgical Headlight | |
Date Initiated by Firm | November 17, 2011 |
Date Posted | November 20, 2012 |
Recall Status1 |
Terminated 3 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 WI 53562
|
For Additional Information Contact | 608-831-2555 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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