FDA-Device2017-06-14Class II
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
Stryker Communications
Hazard
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.
Sold states
Worldwide Distribution - US and Canada
Affected count
57 units
Manufactured in
1410 Lakeside Pkwy Ste 100, N/A, Flower Mound, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2248-2017Don't want to check this manually?
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