Stop using now Medical device recall · FDA · Published November 18, 2020

Shimadzu MH-200S X-Ray System Recall: Ceiling Arm Movement Risk

Shimadzu Medical Systems recalls MH-200S X-Ray systems with ceiling suspended C-arm support due to software causing ceiling arm movement after release. Affected serial numbers listed. Stop using immediately to prevent patient or operator injury.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0556-2021Medical device Shimadzu Medical Systems ›

Stop using this now

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

Take action

Contact the company

Recalling firmShimadzu Medical Systems20101 S Vermont Ave · Torrance, CA 90502-1328

✎ GovInfoNow plain-language explainer

Shimadzu recalls specific models of X-ray systems used for medical imaging because a software issue might cause the ceiling arm to move unexpectedly after the operator releases the movement lever. This could lead to collisions or injuries for patients or medical staff if the system is used without correction. Read more at govinfonow.com/recall/63867-shimadzu-mh-200s-x-ray-system-recall-ceiling-arm-movement.

Source Summary by GovInfoNow · govinfonow.com/recall/63867-shimadzu-mh-200s-x-ray-system-recall-ceiling-arm-movement · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0556-2021

Cite this page

“Shimadzu MH-200S X-Ray System Recall: Ceiling Arm Movement Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63867-shimadzu-mh-200s-x-ray-system-recall-ceiling-arm-movement. Based on FDA recall #Z-0556-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0556-2021%22&limit=1).

Shimadzu Medical Systems recalled the MH-200S system with Ceiling Suspended C-arm Support due to a control software issue that could cause the ceiling arm to move unexpectedly, according to the FDA. The agency announced the Class II recall on Nov. 18, 2020.

How to tell if you have it

Brand: Shimadzu Medical Systems
Product: MH-200S system with Ceiling Suspended C-arm Support
Affected Serial Numbers: 0161K35901, 0161K46901, 0161K58202, 0161K56001, 0161K55702, 0161K55301, 0161K55202, 0161K47102, 0161K46802, 0161K46301, 0161K36501, 0161K36301, 0161K35702, 0161K36202, 40AAE701B001, 0161K49301, 0161K48601, 0161K48501, 0161K36402, 0161K35602, 0161K35202, 0161K56502
Units affected: 22

The hazard

The firm identified a problem with the control software for the ceiling arm of the X-Ray System. This software issue could cause the ceiling arm to move after the operator has released the movement lever, potentially resulting in collision or harm to the patient or system operator.

Context

GovInfoNow's records show Shimadzu Medical Systems has six other recalls on record since Jan. 12, 2018. Other recent recalls of similar products include Canon Alphenix INFX-8000C X-ray System Recall (Dec. 19, 2025), Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025), and Canon Alphenix INFX-8000V X-ray System Recall (Dec. 19, 2025).

How to tell if you have this one

Check if your X-ray system has the model name 'MH-200S' with ceiling suspended C-arm support. Affected units have specific serial numbers listed in the recall notice, including 0161K35901 through 0161K56502.

Brand
Shimadzu Medical Systems
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.

Recall number	Product, codes & lots	Quantity
Z-0554-2021	Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.; Serial Numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, 091X955901	7 units
Z-0555-2021	Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.; Affected Serial Numbers: 41EFCD7A6001 41EFC73A5001, 41EFCD79C001, 41EFD3B9C001, 41EFFF79C001, 41EFD3B9A001, 41EFCD79A001, 41EFFF79A001, 41F005B91001, 41F005B8C001, 41EFCD78B001, 41EFCD77C001, 41E58C776001, 41E58C777001, 41E58C775001, 41E58C773001, 41E58C76B001, 41E58C769001, 41E58C766001, 41E58C765001, 41E58C757001, 41B24774C001, 41B247746001,	23 units
Z-0556-2021	MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.; Affected Serial Numbers: 0161K35901, 0161K46901, 0161K58202, 0161K56001, 0161K55702, 0161K55301, 0161K55202, 0161K47102, 0161K46802, 0161K46301, 0161K36501, 0161K36301, 0161K35702, 0161K36202, 40AAE701B001, 0161K49301, 0161K48601, 0161K48501, 0161K36402, 0161K35602, 0161K35202, 0161K56502	22 units

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately cease using the affected X-ray system to prevent potential collisions or injuries.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

FDA distribution: “US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, New York, North Carolina, Ohio, South Carolina, Tennessee.

Recall timeline

FDA published this recall 28 days after the firm started it.

Nov 18, 2020Firm started the recall
Dec 10, 2020FDA classified it Class II
Dec 16, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63867-shimadzu-mh-200s-x-ray-system-recall-ceiling-arm-movement">Shimadzu MH-200S X-Ray System Recall: Ceiling Arm Movement Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0556-2021 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0556-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.