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
This recall has been terminated (originally issued April 21, 2017).
- Company
- Stryker Communications
- Recall Initiated
- April 21, 2017
- Terminated
- September 20, 2017
- Recall Number
- Z-2248-2017
- Quantity
- 57 units
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US and Canada
Lot / Code Info
Serial Numbers: 7735170-X68377, 7735170-X68397, 7735170-X14846, 7735170-X15688, 7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X68383, 7735170-X68384, 7735170-X68385, 7735170-X68386, 7735170-X68393, 7735170-X68394, 7735170-X68395, 7735170-X68396, 7735170-X68392, 7735170-X68400, 7735170-X68401, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615
Root Cause
Component design/selection
Action Taken
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 comm.techservice@stryker.com. For questions regarding this recall call 972-834-8656.