DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system…
Medical device recall Z-3245-2018. Published in FDA’s Enforcement Report on Oct 3, 2018.
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 Oct 3, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 16 states named
- 108 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?
A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
108, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Nos: A5430000015 A5430000020 A5430000030 A5430000042 A5430000045 A5430000052 A5430000053 A5430000054 A5430000057 A5430000058 A5430000060 A5430000061 A5430000063 A5430000066 A5430000067 A5430000068 A5430000074 A5430000079 A5430000081…
Every code shown here, 1,307 characters
Serial Nos: A5430000015 A5430000020 A5430000030 A5430000042 A5430000045 A5430000052 A5430000053 A5430000054 A5430000057 A5430000058 A5430000060 A5430000061 A5430000063 A5430000066 A5430000067 A5430000068 A5430000074 A5430000079 A5430000081 A5430000085 A5430000089 A5430000095 A5430000096 A5430000100 A5430000105 A5430000106 A5430000107 A5430000108 A5430000119 A5430000121 A5430000124 A5430000125 A5430000130 A5430000131 A5430000132 A5430000133 A5430000137 A5430000143 A5430000144 A5430000149 A5430000156 A5430000162 A5430000165 A5430000166 A5430000172 A5430000176 A5430000177 A5430000183 A5430000184 A5430000199 A5430000206 A5430000207 A5430000215 A5430000218 A5430000222 A5430000224 A5430000225 A5430000226 A5430000228 A5430000229 A5430000234 A5430000237 A5430000238 A5430000242 A5430000246 A5430000247 A5430000248 A5430000249 A5430000263 A5430000264 A5430000272 A5430000275 A5430000276 A5430000279 A5430000281 A5430000285 A5430000293 A5430000295 A5430000296 A5430000297 A5430000298 A5430000299 A5430000300 A5430000303 A5430000304 A5430000305 A5430000306 A5430000311 A5430000312 A5430000313 A5430000320 A5430000321 A5430000322 A5430000323 A5430000324 A5430000331 A5430000332 A5430000338 A5430000350 A5430000351 A5430000354 A5430000357 A5430000358 A5430000359 A5430000360 A5430000368 A5430000369 A5430000374
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 in the states of CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada.
The states and territories these words name
16 states and territories.
Every one of them
- California
- District of Columbia
- Florida
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Minnesota
- Missouri
- Nevada
- New York
- Ohio
- Oregon
- South Carolina
- Tennessee
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?
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 Aug 15, 2018.
- FDA classified it on Sep 25, 2018.
- FDA’s Enforcement Report published it on Oct 3, 2018.
- FDA terminated it on Jun 23, 2020.
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: 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.”
- 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.