Recall Z-1992-2013 ยท KZF Device, Medical Examination, Ac Powered
Stryker Communications
Stryker Visum 300 Ceiling-mounted Exam Light.
| Date | Aug 21, 2013 (initiated Jul 25, 2013) |
| Status | Terminated |
| Reason | Potential incomplete final weld on the drop tube flange. |
| Root cause | Process control |
| Action | The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663. |
| Quantity | 1,375 units |
| Distribution | Worldwide Distribution: US natiowide and to the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.