The Recall Desk
HighFDA (Devices)·Z-2655-2017·Announced 2017-07-05

Shimadzu FDR Visionary X-Ray System Recalled for Tube Shaft Cracks

Shimadzu is recalling FDR Visionary x-ray systems because cracks may develop on the tube holding shaft. The recall covers 1,673 units distributed in the US, Canada, and Japan.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device (cracking shaft) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Shimadzu Medical Systems USA is recalling the FDR Visionary stationary x-ray system, catalog number FDR Visionary Suite. The device is intended for general radiographic and tomographic imaging in hospitals, clinics, and other healthcare facilities. A total of 1,673 units are affected by this recall.

The recall is being conducted because cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. The affected units were distributed nationwide in the United States, as well as in Canada and Japan. Specific serial numbers are listed in the official recall documentation.

Healthcare facilities should contact Shimadzu Medical Systems USA for instructions on how to address the defect. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

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 qualifie
Manufacturer
Shimadzu Medical Systems Usa Com
Category
Medical Device — X-Ray System
Hazard
Affected units
1,673

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Serial No. 0162M4501 thru 0562M45103
  • 3ZC5C2A0C002 thru 3ZC5C1734001
  • D362M42902 thru 0562M41101
  • 41E733E69003
  • MP95A8F5A001 thru MP95A9F6B001

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Shimadzu Medical Systems Usa Com under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Shimadzu Medical Systems Usa Com

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Same hazard · structural defect

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