FDR Visionary Suite recallZ-0232-2018 · Fujifilm Medical Systems U.S.A., Inc. · initiated Jun 15, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fujifilm Medical Systems U.S.A., Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 measures. As FMSUs planned field correction at the affected sites, FMSU will install the additional protective parts preventing the X-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. For further questions, please call (203) 324-2000.
Recall details
- Recall number
- Z-0232-2018
- Status
- Terminated
- Initiated by the company
- Jun 15, 2017
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 3
- Product code
- KPR
- FDA submissions
- K152294
- Distribution
- US Distribution.
Product description
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.
Code information (models, lots, serial numbers)
UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001. Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FDR Visionary Suite 566-16130-23Shimadzu Corporation · System, X-Ray, Stationary4 recalls0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K152294 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- FDR Visionary Suite 566-16130-31Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- FDR Visionary Suite 566-16130-33Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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