Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0402-2013 · Posted 2012-11-20

Recalling FirmKerr Corporation
Recall StatusTerminated
Product CodeEBA
Date Initiated2011-11-17
Date Terminated2012-11-20
Product Quantity1330 units

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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