FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Summary
The FDA issued a Class II for FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566- by FUJIFILM Healthcare Americas Corporation. 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 curr.
Details
Source
Device Recall
External ID
Z-1299-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Lot/Code Info: Model Number: CH-200; (1) Version: 566-16130-23; UDI-DI: 04540217052226; Serial numbers: MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001; (2) Version: 566-16130-31; UDI-DI: 04540217057436; Serial numbers: MP95AA783001; (3) Version: 566-16130-33; UDI-DI: 04540217057450; Serial numbers: MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;
Quantity Affected: 16 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-09
Company
Lexington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 207 device recalls issued in the same week, part of 403 device-related FDA actions this month.
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FUJIFILM Healthcare Americas Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FUJIFILM Healthcare Americas Corporation have FDA actions?
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1299-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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