Recall Z-1299-2026 ยท KPR System, X-Ray, Stationary
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
| Date | Feb 5, 2026 (initiated Jan 9, 2026) |
| Status | Open, Classified |
| Reason | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke. |
| Root cause | Process control |
| Action | On January 9, 2026 URGENT: MEDICAL DEVICE RECALL letters were emailed to customers. Actions to be taken: Please pay attention to the following points until the work is completed. " For safety reasons, please turn off the breaker of the distribution board to which the power cord of the unit is connected after turning off the power of the unit according to the operation manual. " Do not forget to turn off the breaker of the distribution board until the replacement of the contactor is completed. 1) Please post this notification on or near the device 2) Please complete and return the Field Action |
| Quantity | 16 units |
| Distribution | US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152294 | FDR Visionary Suite Shimadzu Corporation, Jul 15, 2016 |