Recall Z-1527-05 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Fischer Imaging Corporation
Electrophysiology Imaging System
| Date | Sep 9, 2005 (initiated Apr 28, 2005) |
| Status | Terminated |
| Reason | Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. |
| Root cause | Other |
| Action | Consignees were notified by certified letter on 04/27/2005. |
| Quantity | 5 units |
| Distribution | Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.