Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option
Medical device recall Z-0534-2021. Published in FDA’s Enforcement Report on Dec 16, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 16, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 26 states named
- 115 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
115 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SMS ID / Serial Number SMS20200126 41F41E7A3011, SMS20200182 41F41E7A5006, SMS20200184 41F41E7A5008, SMS20180073 41F41DD7C006, SMS20180068 41F41DD7C003, SMS20180075 41F41DD7C007, SMS20180349 41F41DD85007, SMS20180350 41F41DD85009,…
Every code shown here, 1,999 characters
SMS ID / Serial Number SMS20200126 41F41E7A3011, SMS20200182 41F41E7A5006, SMS20200184 41F41E7A5008, SMS20180073 41F41DD7C006, SMS20180068 41F41DD7C003, SMS20180075 41F41DD7C007, SMS20180349 41F41DD85007, SMS20180350 41F41DD85009, SMS20180351 41F41DD86007, SMS20180448 41F41DD88001, SMS20190308 41F41E798002, SMS20190335 41F41E799002, SMS20190383 41F41E79A010, SMS20200033 41F41E79B001, SMS20200034 41F41E79B005, SMS20200219 41F41E7A6012, SMS20200301 41F41E7A6051, SMS20200339 41F41E7A7006, SMS20190016 41F41DD88010, SMS20190138 41F41DD8B007, SMS20190268 41F41E797001, SMS20190307 41F41E798003, SMS20200211 41F41E7A6005, SMS20200232 41F41E7A6020, SMS20200236 41F41E7A6024, SMS20200244 41F41E7A6025, SMS20200245 41F41E7A6026, SMS20180141 41F41DD83007, SMS20190008 41F41DD88007, SMS20190009 41F41DD88008, SMS20200325 41F41E7A6055, SMS20180076 41F41DD81002, SMS20190212 41F41DD8C012, SMS20200059 41F41E7A1007, SMS20200212 41F41E7A6010, SMS20200279 41F41E7A6041, SMS20200324 41F41E7A7002, SMS20200332 41F41E7A7005, SMS20200332 41F41E7A7005, SMS20190129 41F41DD8A018, SMS20190213 41F41DD8C013, SMS20200095 41F41E7A2004, SMS20200087 41F41E7A2006, SMS20200088 41F41E7A2007, SMS20200116 41F41E7A3002, SMS20200117 41F41E7A3003, SMS20180205 41F41DD83023, SMS20180230 41F41DD84006, SMS20190171 41F41DD8C002, SMS20190045 41F41DD89003, SMS20180374 41F41DD87004, SMS20200159 41F41DD87004, SMS20190189 41F41DD8C008, SMS20180117 41F41DD82008, SMS20180096 41F41DD82009, SMS20180097 41F41DD82010, SMS20180185 41F41DD83019, SMS20200129 41F41E7A4002, SMS20200130 41F41E7A4003, SMS20200131 41F41E7A4004, SMS20200132 41F41E7A4005, SMS20200206 41F41E7A6004, SMS20180242 41F41DD84019, SMS20190076 41F41DD89010, SMS20190113 41F41DD8A009, SMS20190092 41F41DD89013, SMS20200208 41F41E7A6002, SMS20180066 41F41DD7C004, SMS20180067 41F41DD7C005, SMS20190367 41F41E799010, SMS20190075 41F41DD89009, SMS20200096 41F41E7A2005, SMS20200280 41F41E7A6042, SMS20200348 41F41E7A7004, SMS20180115 41E09E963008, SMS20180082 41F41DD81005,…
FDA’s list runs to 2,986 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
26 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kentucky
- Louisiana
- Michigan
- Minnesota
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 9, 2020.
- FDA classified it on Dec 4, 2020.
- FDA’s Enforcement Report published it on Dec 16, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Shimadzu Medical Systems, of Torrance, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,986 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.