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
Recall
- Recall Number
- Z-2248-2017
- Event Number
- 77261
- Firm
- Stryker Communications
- FEI Number
- 3002975342
- Product Code
- KZF
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- April 21, 2017
- Terminated
- September 20, 2017
- Address
- 1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026
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
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.
Stryker Communications sent an Urgent Medical Device Recall letter to all affected customers. A Stryker Representative will contact their facility to schedule a service visit. to replace the adapter assembly to resolve the tolerance issue affected units. Customers with questions were instructed to Stryker Technical Support at 800-243-5135 or [email protected]. For questions regarding this recall call 972-834-8656.
Worldwide Distribution - US and Canada
57 units