Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is…
Medical device recall Z-1691-2019. Published in FDA’s Enforcement Report on Jun 5, 2019.
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 Jun 5, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 288 systems 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?
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
288 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 5143M3IJ100002P 5143M3IJ100010M 5143M3IJ600013B 5143M3HJ500001Y 5143M3IK400005T 513YM3IK100001A 5143M3IJ600014H 5143M3JK400005Y 5143M3IJ400007P 5143M3HK400003P 52VUM3IKA00008M 513YM3IJA00001X 5143M3JJ400007E 5143M3JJ400006K…
Every code shown here, 2,000 characters
Serial Numbers: 5143M3IJ100002P 5143M3IJ100010M 5143M3IJ600013B 5143M3HJ500001Y 5143M3IK400005T 513YM3IK100001A 5143M3IJ600014H 5143M3JK400005Y 5143M3IJ400007P 5143M3HK400003P 52VUM3IKA00008M 513YM3IJA00001X 5143M3JJ400007E 5143M3JJ400006K 52VUM3HK800003X 52VUM3IKA00009W 5143M3JJ300001K 5143M3HJ600003K 5143M3JJ300002X 5143M3JJ300003J 5143M3IJ800008L 5143M3IK400003Z 5149M3IK400001H 5149M3IK400002K 5143M3HK400002V 52VUM3IKA00016E 5143M3HK300004E 514GM3HK100005L 5143M3JK100012J 5143M3IJC00001Y 5143M3JK100003Z 5143M3JK100002B 5143M3HK600006E 5143M3IK400002J 514GM3HK100002R 5143M3HK300007N 52VUM3HK800002F 5143M3HK300010P 52VUM3IK800004K 5143M3IJ100005R 5143M3IK300002J 5143M3HJA00002K 514GM3IK400001L 5143M3JJ200011L 5143M3JJ300012N 5143M3IJ600007N 5143M3IHC00003Y 5143M3IHC00004N 5143M3IHC00015L 5143M3IHC00013X 5143M3DHB00001M 5143M3IHC00014H 5143M3RJ100002V 5143M3JJ200004Y 5143M3JJ200005X 5143M3JK400008N 5143M3JK100015B 5143M3HJA00006P 5143M3JJ200012Z 5143M3IK600005J 5143M3JK400013K 5143M3JJ700004K 5143M3IHC00012Z 514GM3JK300001A 514GM3HK600001T 5143M3IJ800011E 5143M3IK300008R 5143M3IHC00019T 5143M3IJ100001Y 5143M3JK400009V 5143M3HK300017E 5143M3IJ100003X 5143M3HK300001F 5143M3HJA00010W 5143M3JJC00004Y 5143M3GK500006P 5143M3IK400004F 513YM3IK400001W 5143M3JK400007B 5143M3JK400004M 5143M3JK400006R 5143M3IHC00008E 5143M3JJ200016T 5143M3IJ800013Y 5143M3JK100006N 5143M3JK400014E 5143M3IJ600011M 5143M3IJ300004W 5143M3RJ100001M 5143M3JJ200014F 5143M3JJ200017Y 5143M3IJ400003R 5143M3IJ400004B 5143M3HJ900003W 5143M3HJ900002V 5143M3IJ200002F 5143M3IJ600008K 5143M3JJ300011Z 5143M3HJ900006H 5143M3JJ200001F 5143M3JJ200002M 5143M3HJA00004Y 5143M3HJA00005A 5143M3HJ900004M 5143M3HJA00007D 5143M3GK500002Y 5143M3JJ400002X 5143M3HJ500005P 5143M3HJ500006W 5143M3IJ600006W 5143M3HJ900005J 514GM3HK100001E 5143M3HK300018W 5143M3JJ700003D 5143M3JJ700002R 5143M3JK100014L 5143M3HK300006Z 5143M3JJ700005W 5143M3IJ800001B 5143M3IJ800002V 5143M3IJ800005X 5143M3IJ800003J 5143M3IJ800004F 5143M3JJ700001V…
FDA’s list runs to 4,623 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?
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 May 6, 2019.
- FDA classified it on May 30, 2019.
- FDA’s Enforcement Report published it on Jun 5, 2019.
- FDA terminated it on Jun 10, 2020.
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: 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 4,623 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.