Recall Z-0044-2026 ยท KPR System, X-Ray, Stationary
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
| Date | Oct 7, 2025 (initiated Sep 15, 2025) |
| Status | Open, Classified |
| Reason | It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting. |
| Root cause | Device Design |
| Action | On September, 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Perform the daily inspection described in the operation manual to check for wobbles or shakes, misalignment of the light irradiation position, etc. If any abnormality is found, discontinue use and contact Technical Assistance Center (TAC). When rotating the X-ray tube unit, do not hit the stopper at the end. Do not rotate the X-ray tube over or near the patient. Please post this notice on or near the device. Complete and return the response form provided. Fujifilm Service Engineers will in |
| Quantity | 16 units |
| Distribution | Domestic: AK, CA, FL, IL, MA, 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 |