Z-2248-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- April 21, 2017
- Termination Date
- September 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57 units
Product Description
Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
Reason for Recall
The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
Distribution Pattern
Worldwide Distribution - US and Canada
Code Information
Serial Numbers: 7735170-X68377, 7735170-X68397, 7735170-X14846, 7735170-X15688, 7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X68383, 7735170-X68384, 7735170-X68385, 7735170-X68386, 7735170-X68393, 7735170-X68394, 7735170-X68395, 7735170-X68396, 7735170-X68392, 7735170-X68400, 7735170-X68401, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615