Recall Z-2248-2017— Stryker Communications
Class II · Terminated
Class II FDA medical device recall by Stryker Communications, initiated 2017-04-21, terminated 2017-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Stryker Communications
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-21
- Terminated
- 2017-09-20
- Firm location
- Flower Mound, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.