The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2654-2017·Announced 2017-07-05

Shimadzu RADspeed Pro X-Ray Systems Recalled for Tube Shaft Cracks

Shimadzu is recalling RADspeed Pro stationary x-ray systems because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 that could lead to equipment failure, 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 1,673 units of the RADspeed Pro stationary x-ray system. The recall is due to a defect where 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, including Alaska, Arkansas, Arizona, California, Connecticut, Florida, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin, and Hawaii. The units were also distributed in Canada and Japan.

Healthcare facilities should contact Shimadzu Medical Systems USA for instructions on how to address the defect. The recall number is Z-2654-2017.

The recalled product

Product
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Manufacturer
Shimadzu Medical Systems Usa Com
Category
Medical Device — Diagnostic Imaging
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 →

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