Z-1299-2026Class II

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

Name: Z-1299-2026 FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2026-01-09
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2026-01-09 / Open, Classified / root cause: manufacturing process

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) on 2026-01-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1299-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-09
Posted: 2026-02-05
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 9, 2026 URGENT: MEDICAL DEVICE RECALL letters were emailed to customers. Actions to be taken: Please pay attention to the following points until the work is completed. " For safety reasons, please turn off the breaker of the distribution board to which the power cord of the unit is connected after turning off the power of the unit according to the operation manual. " Do not forget to turn off the breaker of the distribution board until the replacement of the contactor is completed. 1) Please post this notification on or near the device 2) Please complete and return the Field Action Verification Form attached to this communication. Responding with the information requested is essential for ensuring appropriate action is taken. 3) Please contact Technical Assistance Center (TAC) at 1-888-FUJIMED (1-888-385-4633) to open a service ticket. 4) Please report any known adverse events to FDA via MedWatch.
Quantity in commerce: 16 units
Distribution: US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1299-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1299-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05

Product code KPR

K152294Class IIFDR Visionary SuiteShimadzu Corporation / cleared 2016-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)