Stryker Communications recalls Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of…

Recall date

April 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2248-2017

FDA classification

Class II

Brand / firm

Stryker Communications

Sold / distributed

Worldwide Distribution - US and Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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