U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Light, surgical headlight - Product Code EBA
원인
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.
조치
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.
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.
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
제품 설명
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.