Agfa DX-D 100 system-Digital Radiography mobile X-ray System
Medical device recall Z-1462-2024. Published in FDA’s Enforcement Report on Apr 10, 2024.
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 Apr 10, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 541 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?
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400
541 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 5414904272725YG US Serial Numbers: Serial Number A5411001002 A5411001003 A5411001005 A5411001033 A5411001034 A5411001035 A5411001036 A5411001037 A5411001038 A5411001039 A5411001064 A5411001065 A5411001066 A5411001067 A5411001068…
Every code shown here, 1,998 characters
UDI: 5414904272725YG US Serial Numbers: Serial Number A5411001002 A5411001003 A5411001005 A5411001033 A5411001034 A5411001035 A5411001036 A5411001037 A5411001038 A5411001039 A5411001064 A5411001065 A5411001066 A5411001067 A5411001068 A5411001069 A5411001073 A5411001080 A5411001081 A5411001087 A5411001089 A5411001090 A5411001097 A5411001098 A5411001099 A5411001105 A5411001110 A5411001112 A5411001149 A5411001151 A5411001152 A5411001162 A5411001163 A5411001164 A5411001165 A5411001174 A5411001175 A5411001176 A5411001177 A5411001201 A5411002007 A5411002023 A5411002024 A5411002025 A5411002029 A5411002030 A5411002031 A5411002032 A5411002033 A5411002047 A5411002048 A5411002049 A5411002051 A5411002052 A5411002053 A5411002054 A5411002058 A5411002059 A5411002060 A5411002061 A5411002063 A5411002064 A5411002065 A5411002070 A5411002071 A5411002072 A5411002073 A5411002074 A5411002076 A5411002078 A5411002082 A5411002083 A5411002084 A5411002085 A5411002128 A5411002129 A5411002130 A5411002131 A5411002143 A5411002144 A5411002145 A5411002146 A5411002147 A5411002152 A5411002160 A5411002161 A5411002162 A5411002171 A5411002172 A5411002173 A5411002182 A5411002183 A5411002184 A5411002185 A5411002186 A5411002187 A5411002188 A5411002199 A5411002200 A5411002201 A5411002202 A5411002203 A5411002204 A5411002205 A5411002206 A5411002208 A5411002212 A5411002234 A5411002236 A5411002247 A5411002249 A5411002257 A5411002263 A5411002265 A5411002269 A5411003022 A5411003023 A5411003024 A5411003027 A5411003028 A5411003031 A5411003032 A5411003038 A5411003039 A5411003040 A5411003042 A5411003044 A5411003045 A5411003047 A5411003048 A5411003049 A5411003051 A5411003054 A5411003055 A5411003056 A5411003057 A5411003058 A5411003059 A5411003060 A5411003061 A5411003062 A5411003063 A5411003065 A5411003068 A5411003070 A5411003071 A5411003072 A5411003073 A5411003074 A5411003080 A5411003081 A5411003082 A5411003083 A5411003084 A5411003085 A5411003086 A5411003090 A5411003091 A5411003092 A5411003093 A5411003094 A5411003096…
FDA’s list runs to 6,622 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.
Worldwide distribution - US Nationwide and the countries of Canada, Argentina, Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom.
These words name no state.
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.
The words say it went outside the United States too.
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 Feb 23, 2024.
- FDA classified it on Apr 2, 2024.
- FDA’s Enforcement Report published it on Apr 10, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Agfa N.V., of Mortsel, Belgium.
- 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 6,622 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
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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.