Use cautionMedical device recall · FDA · Published November 9, 2020
Shimadzu Mobile X-Ray System Recall: Improper Handle Bolts Risk Injury
Shimadzu recalls Mobile X-Ray System (MX8) with adjustable handle option due to potential improper bolts causing unsafe operation. Affected units have specific SMS IDs listed.
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
Take action
Contact the company
📍Recalling firmShimadzu Medical Systems20101 S Vermont Ave · Torrance, CA 90502-1328
“Shimadzu Mobile X-Ray System Recall: Improper Handle Bolts Risk Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63954-shimadzu-mobile-x-ray-system-recall-improper-handle-bolts-risk. Based on FDA recall #Z-0534-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0534-2021%22&limit=1).
Shimadzu Medical Systems recalled MobileDaRt Evolution (MX8 Version) mobile X-Ray systems with adjustable handles due to improper bolts that may cause injury during operation, the FDA said on 2020-11-09.
How to tell if you have it
Brand: Shimadzu
Product: MobileDaRt Evolution (MX8 Version)
Feature: Adjustable handle option
Origin: Made in Japan
Units affected: 115
The hazard
The adjustable handle option may have been installed with improper bolts, which could result in improper driving operation and lead to harm of individuals around the device.
Context
GovInfoNow's records show Shimadzu Medical Systems has 6 other recalls on record since 2018-01-12. Other recent recalls of similar products include GE Optima XR220amx Mobile X-Ray System Recall (2026-06-05), GE Optima XR240amx Mobile X-Ray System Recall (2026-06-05) and GE Optima XR200amx Mobile Radiography System Recall (2026-06-05).
How to tell if you have this one
Check if your device has the adjustable handle option. Affected units have specific SMS IDs listed in the recall notice, such as SMS20200126 41F41E7A3011.
Brand
Shimadzu
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for the adjustable handle option on your Shimadzu Mobile X-Ray System (MX8 version).
Verify SMS ID
Confirm your device's SMS ID matches the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 26 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0534-2021 (November 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0534-2021 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.