FDR Visionary Suite recallZ-1898-2024 · FUJIFILM Healthcare Americas Corporation · initiated Apr 11, 2024
Open, Classified
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 Healthcare Americas Corporation 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
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
FDA root cause category: Component design/selection
What the company is doing
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. Please contact our field action coordinator, Chaitrali Kulkarni, via email at [email protected], if you have any further questions regarding this field action.
Recall details
- Recall number
- Z-1898-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 11, 2024
- Posted by the FDA
- May 24, 2024
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 18 units
- Product code
- KPR
- FDA submissions
- K152294
- Distribution
- US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
Product description
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
Code information (models, lots, serial numbers)
UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002
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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