Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a…
Medical device recall Z-0451-2016. Published in FDA’s Enforcement Report on Dec 30, 2015.
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 30, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 297 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?
The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
297 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 41DBBB534001 41DBBB534004 41DBBB534002 41DBBB534005 41DBBB534006 41DBBB536001 41DBBB536007 41DBBB536008 41DBBB536009 41DBBB536010 41DBBB539001 41DBBB539002 41DBBB539003 41DBBB539004 41DBBB53A001 M1DBBB547001 M1DBBB547002…
Every code shown here, 2,000 characters
Serial No. 41DBBB534001 41DBBB534004 41DBBB534002 41DBBB534005 41DBBB534006 41DBBB536001 41DBBB536007 41DBBB536008 41DBBB536009 41DBBB536010 41DBBB539001 41DBBB539002 41DBBB539003 41DBBB539004 41DBBB53A001 M1DBBB547001 M1DBBB547002 M1DBBB547003 M1DBBB547004 M1DBBB547005 M1DBBB547006 M1DBBB547007 M1DBBB548001 M1DBBB548002 41DBBA136010 41DBBA136014 41DBBA145008 41DBBA145009 41DBBA145016 41DBBA141006 41DBBA147004 41DBBA149021 41DBBA149022 41DBBA132003 41DBBA142001 41DBBA14A004 41DBBA132001 41DBBA132010 41DBBA141012 41DBBA142012 41DBBA147017 41DBBA147028 41DBBA146015 41DBBA146017 41DBBA142004 41DBBA142014 41DBBA148002 41DBBA131018 41DBBA131020 41DBBA136006 41DBBA136011 41DBBA141013 41DBBA14A010 41DBBA142019 41DBBA142020 41DBBA149005 41DBBA145024 41DBBA143002 41DBBA141009 41DBBA136003 41DBBA136004 41DBBA132002 41DBBA146021 41DBBA146028 41DBBA14A007 41DBBA141001 41DBBA142015 41DBBA146002 41DBBA147008 41DBBA14A015 41DBBA132012 41DBBA132016 41DBBA131004 41DBBA136013 41DBBA142009 41DBBA137001 41DBBA146019 41DBBA14A022 41DBBA147013 41DBBA146006 41DBBA146014 41DBBA146037 41DBBA146044 41DBBA146045 41DBBA147006 41DBBA143005 41DBBA147007 41DBBA145005 41DBBA14B005 41DBBA132015 41DBBA131016 41DBBA146043 41DBBA131001 41DBBA145015 41DBBA145018 41DBBA131011 41DBBA147015 41DBBA14A014 41DBBA14A017 41DBBA137005 41DBBA132017 41DBBA147019 41DBBA14A023 41DBBA147016 41DBBA136002 41DBBA146039 41DBBA145014 41DBBA132006 41DBBA146009 41DBBA132011 41DBBA144004 41DBBA14A024 41DBBA142017 41DBBA14A002 41DBBA14A012 41DBBA145007 41DBBA149002 41DBBA147021 41DBBA136007 41DBBA136008 41DBBA142002 41DBBA142010 41DBBA145026 41DBBA131005 41DBBA131007 41DBBA149006 41DBBA14A005 41DBBA14A013 41DBBA149017 41DBBA149010 41DBBA149011 41DBBA14B004 41DBBA147018 41DBBA14C001 41DBBA14C004 41DBBA149008 41DBBA148001 41DBBA149003 41DBBA149007 41DBBA149004 41DBBA145025 41DBBA145029 41DBBA145031 41DBBA145033 41DBBA14B002 41DBBA133005 41DBBA131003 41DBBA133009 41DBBA145038 41DBBA147020 41DBBA142011 41DBBA145003 41DBBA145011…
FDA’s list runs to 3,923 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 Distribution and Internationally to Canada
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 10, 2015.
- FDA classified it on Dec 18, 2015.
- FDA’s Enforcement Report published it on Dec 30, 2015.
- FDA terminated it on Oct 27, 2016.
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: Letter.
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 3,923 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.