Recall Z-1898-2024 ยท KPR System, X-Ray, Stationary
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite - 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. Model/Catalog Number: 566-16130-23 566-16130-33
| Date | May 24, 2024 (initiated Apr 11, 2024) |
| Status | Open, Classified |
| Reason | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury |
| Root cause | Component design/selection |
| Action | FUJIFILM Healthcare Americas Corporation (FUJIFILM) issued Urgent -FIrst Notice letter via email on 4/11/24. Letter states reason for recall, health risk and action to take: 1)Please complete and return the form attached on page 3 of this communication. Providingthe response with the information requested is essential for ensuring appropriate action istaken 2)Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a serviceticket. 3)Until your upgrade is scheduled and completed, you can continue to safely use FDRVisionary Suite, however, inspect the bolts prior to use. Pleas |
| Quantity | 18 units |
| Distribution | US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152294 | FDR Visionary Suite Shimadzu Corporation, Jul 15, 2016 |