Z-0044-2026Class II

FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

Name: Z-0044-2026 FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2025-09-15
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2025-09-15 / Open, Classified / root cause: design

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 on 2025-09-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0044-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-15
Posted: 2025-10-07
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 16 units
Distribution: Domestic: AK, CA, FL, IL, MA, NH, OH, WI.
Product codes and lots: Model/Version Number: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33; UDI-DI: (1) 04540217052226, (2) 04540217057436, (3) 04540217057450; Serial Numbers: (1) MP95A8F5A001, MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001, (2) MP95AA783001, (3) MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA988002;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0044-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0044-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-07

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)