PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 14, 2017 Initiated: April 21, 2017 #Z-2248-2017

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.

Details

Recalling Firm
Stryker Communications
Units Affected
57 units
Distribution
Worldwide Distribution - US and Canada
Location
Flower Mound, TX

Frequently Asked Questions

What product 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. Recalled by Stryker Communications. Units affected: 57 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2248-2017.