Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-770034
FDA device recall Z-0402-2013 · posted 2012-11-20 · Terminated
Recall details
- Recalling firm
- Kerr Corporation
- 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 taken
- 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
- Status
- Terminated
- Product code
- EBA
- Quantity affected
- 1330 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
- Date initiated
- 2011-11-17
- Date posted
- 2012-11-20
- Date terminated
- 2012-11-20
- Location
- Middleton, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.