Recall Z-2248-2017 ยท KZF Device, Medical Examination, Ac Powered
Stryker Communications
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
| Date | Apr 21, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 57 units |
| Distribution | Worldwide Distribution - US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.