Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Medical device recall Z-1414-2023. Published in FDA’s Enforcement Report on Apr 26, 2023.
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 26, 2023. 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
- 935 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?
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
935 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 08806088582412 GM85 systems S/N: 5143M3JK100005D 52VUM3IK800002X 52VYM3HMA00001B 52WAM3IM500003W 55Y9M3IN100001W 562GM3HN400002J 562GM3IN300005E 562GM3IR300002Z 562GM3JR200005D 562GM3JR200006F 562GM3JR200007M 562GM3JR300001B…
Every code shown here, 1,993 characters
UDI-DI: 08806088582412 GM85 systems S/N: 5143M3JK100005D 52VUM3IK800002X 52VYM3HMA00001B 52WAM3IM500003W 55Y9M3IN100001W 562GM3HN400002J 562GM3IN300005E 562GM3IR300002Z 562GM3JR200005D 562GM3JR200006F 562GM3JR200007M 562GM3JR300001B 5637M3HN200004T 56T5M3IRB00001R 5143M3HK600001D 5143M3IK400009H 5143M3IK600001Y 5143M3IK600003N 5143M3IK600004K 5143M3JK500002P 5143M3JK500003W 5143M3JK500005V 5143M3JK500007L 5637M3JN400002A 52VUM3HM600019F 52VUM3HM700001X 52VUM3HM700002Z 52VUM3HM700003V 52VUM3HM700004R 52VUM3HM700005D 52VUM3IKA00018R 52VUM3IM700001A 52VUM3IM700003J 52VYM3IM500002F 52VYM3IM500007Y 52VYM3IM500009A 52VYM3IM500012T 5631M3RNC00007W 5637M3RR400005N 5143M3DHB00001M 5143M3HJ500005P 5143M3HJ500006W 5143M3HJ900005J 5143M3IJ600006W 5143M3JJ400002X 5143M3IJ800001B 5143M3IJ800002V 5143M3IJ800003J 5143M3IJ800004F 5143M3IJ800005X 5143M3JJ700005W 52VUM3HM600005L 52VUM3HM600006F 52VUM3HM600008W 52VUM3HM600009N 52VUM3HM600010V 52VUM3HM600017P 52VUM3IM600005M 5637M3IR400001Y 5637M3IR400006P 5637M3RR400006V 52VUM3IM600003E 5631M3RNC00004B 5637M3HR300004X 56F9M3HR800026V 56KBM3JT600001D 5143M3IJC00001Y 5143M3JK100002B 5143M3JK100003Z 52VUM3JM400002T 5637M3INA00005L 52VYM3IM500003K 52VYM3IM500006H 52VYM3IM500008J 52VYM3IM500010L 5143M3IJ300002Y 5143M3IJ300006N 5637M3HR400002M 5637M3IR400004N 52VUM3HM400005Y 52VUM3HM400009V 52VUM3HM400010W 52VUM3JM400006H 52VUM3JM400003X 52VYM3IM500001B 52VYM3IM500005Z 55GFM3HM500002P 52VUM3HM600016H 52VUM3IM600001A 5637M3INA00018L 56L2M3HRA00007A 5143M3IHC00014H 5143M3JJ200004Y 5143M3JJ200005X 5143M3RJ100002V 55GFM3IM400001D 55GFM3IM400003Y 55GFM3IM400005B 55GFM3IM400007V 5143M3IJ100002P 5143M3IJ100010M 5143M3IJ600013B 562GM3IR300004M 5143M3IHC00003Y 5143M3IHC00004N 5143M3IHC00013X 5143M3IHC00015L 5143M3JK100012J 514GM3HK100005L 5631M3INC00001H 56F9M3HR700009A 52VUM3HM600001X 52VUM3HM600007Y 52VUM3HM600012Z 5143M3JJ300006H 5143M3JJ300007T 5637M3HN400004B 55GFM3IM400004R 55GFM3IM400008P 55GFM3IM400010H 5143M3HK700001D 52VUM3HM600011E…
FDA’s list runs to 15,024 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.
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.
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 Mar 8, 2023.
- FDA classified it on Apr 19, 2023.
- FDA’s Enforcement Report published it on Apr 26, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- NeuroLogica Corporation, of Danvers, MA.
- 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 15,024 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.