Recall Z-0232-2018 ยท KPR System, X-Ray, Stationary
Fujifilm Medical Systems U.S.A., Inc.
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
| Date | Jun 15, 2017 |
| Status | Terminated |
| Reason | A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. |
| Root cause | Device Design |
| Action | FUJIFILM Medical Systems U.S. A. Inc. (FMSU) sent "Urgent: Medial Device Correction" recall notification letter dated June 21, 2017 to all Customers. Customers were notified of the recall, potential issue, potential hazard, description of the issue, the actions planned to correct the issue, the actions to be taken by the customer and contact information. A Customer Feedback Form was provided accompanying the letter. FMSU service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective mea |
| Quantity | 3 |
| Distribution | US Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152294 | FDR Visionary Suite Shimadzu Corporation, Jul 15, 2016 |