Z-2655-2017Class II

SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general...

Name: Z-2655-2017 SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general...
Creator: Shimadzu Medical Systems Usa Com
Published: 2017-05-23
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2017-05-23 / Terminated / root cause: design

FDA source

Shimadzu Medical Systems Usa Com began a recall of SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body... on 2017-05-23. FDA classified it as Class II and gives the reason as "Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2655-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-23
Posted: 2017-06-29
Terminated: 2019-10-01
Recalling firm: Shimadzu Medical Systems
Product: SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
Product code: KPR System, X-Ray, Stationary
Reason for recall: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Root cause tag: design
FDA root cause: Device Design
Action: Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers. The firm will implement a voluntary recall/field corrective action to add protective parts preventing the x-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. Customers with questions were instructed to call 800-228-1429.
Quantity in commerce: 1673 units total
Distribution: Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan
Product codes and lots: Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2655-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2653-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29
Z-2654-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29
Z-2655-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

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)