Agency classClass IIOur severity:High FDA (Devices)·Z-2653-2017·Announced 2017-07-05

Shimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks

Shimadzu Medical Systems is recalling ceiling-type X-ray tube supports 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 and potential patient injury, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Shimadzu Medical Systems USA is recalling 1,673 units of the Ceiling Type X-ray Tube Support CH-200/CH-200M. 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 devices are designed to hold an X-ray tube unit and collimator for performing radiography of patients in standing or supine positions. The recall covers units distributed nationwide in the United States, as well as in Canada and Japan.

Healthcare facilities should contact Shimadzu Medical Systems USA for instructions on how to address the defect. The specific serial numbers affected are listed in the agency's recall record.

The recalled product

Product: SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or…
Manufacturer: Shimadzu Medical Systems Usa Com
Category: Medical Device — Radiology Equipment
Hazard: structural-failure
equipment-malfunction
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 →

Same manufacturer · Shimadzu Medical Systems Usa Com

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Same hazard · structural failure