Z-1898-2024Class II

FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal...

Name: Z-1898-2024 FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal...
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2024-04-11
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2024-04-11 / Open, Classified / root cause: design

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body... on 2024-04-11. FDA classified it as Class II and gives the reason as "Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury". 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-1898-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-11
Posted: 2024-05-24
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: 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
Product code: KPR System, X-Ray, Stationary
Reason for recall: Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 18 units
Distribution: US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
Product codes and lots: UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1898-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1898-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24

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)