FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FDA device recall Z-0044-2026 · posted 2025-10-07 · Open, Classified
Recall details
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Reason for recall
- 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.
- Action taken
- 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 install countermeasure parts that will prevent the X-ray tube support from coming off even if the shaft is damaged. Please contact Technical Assistance Center (TAC) at 1-888-385-4633 or 1-888-FUJIMED for any functional/correction questions as well as to schedule your correction.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 16 units
- Distribution
- Domestic: AK, CA, FL, IL, MA, NH, OH, WI.
- Date initiated
- 2025-09-15
- Date posted
- 2025-10-07
- Location
- Lexington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FDR Visionary Suite (K152294) | Shimadzu Corporation | 2016-07-15 |