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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

NeuroLogica Corporation: Mobile X-ray System GM85 Recalled Due to Moving Arm Frame Welding Issue

Agency Publication Date: February 9, 2024
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Summary

NeuroLogica Corporation is recalling 261 units of the Samsung Digital Diagnostic Mobile X-ray System, Model GM85, because of a welding defect in the moving arm frame. This defect can cause the mobile x-ray arm to fail and fall unexpectedly. This recall affects devices distributed nationwide in the United States, and the firm notified customers of the issue via e-mail.

Risk

The welding issue in the frame of the moving arm presents a significant risk of the arm falling during use, which can lead to serious bodily harm or impact injuries for both patients and healthcare providers.

What You Should Do

  1. Locate the serial number on your Samsung Digital Diagnostic Mobile X-ray System, Model GM85 to see if it is among the 261 affected units. Affected serial numbers include 5143M3HK400010M, 5143M3IJ800012D, 5143M3IK400005T, 5149M3IK400001H, and others listed in the product database.
  2. Identify the UDI-DI code 08806088582412 on the device labeling to confirm the product identity.
  3. If your device is identified as part of this recall, contact your healthcare facility's clinical engineering department or the manufacturer immediately.
  4. Contact NeuroLogica Corporation to discuss the necessary corrective actions and to arrange for an inspection or repair of the arm frame welding.
  5. For further instructions regarding the device and potential refund or repair options, contact the manufacturer or your healthcare provider.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/instruction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Samsung Digital Diagnostic Mobile X-ray System, Model GM85
Model / REF:
GM85
UPC Codes:
08806088582412
Lot Numbers (261):
5143M3HK400010M
5143M3IJ800012D
5143M3IK400005T
5149M3IK400001H
5149M3IK400002K
5143M3IK400003Z
5143M3GK500001H
513YM3IK100001A
5143M3HJ500001Y
5143M3IJ600014H
5143M3HK400002V
5143M3JK400005Y
5143M3HJ900001L
5143M3IJ400007P
5143M3HK400007T
5143M3HK400003P
513YM3IJA00001X
5143M3JJ400007E
5143M3IJ400006V
5143M3JJ400006K
5143M3JK400009V
5143M3IJ200001D
5143M3JJC00004Y
5143M3JJ200017Y
5143M3IHC00009M
5143M3IJ100011V
5143M3JJ300001K
5143M3HJ600003K
5143M3IK300002J
5143M3JJ300003J
5143M3JJ300002X
5143M3JK400011A
5143M3HK300016Y
5143M3IJ800008L
5143M3IJ600013B
5143M3IJ100010M
5143M3IJ100002P
5143M3HK300011R
5143M3HK200004H
5143M3HK200006K
5143M3JJC00001X
5143M3IJ100009B
5143M3IJ100006J
5143M3HK300017E
5143M3JK400006R
5143M3JK400007B
5143M3JK400004M
5143M3HK300004E
5143M3IJ600011M
5143M3JK100012J

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93803
Status: Active
Manufacturer: NeuroLogica Corporation
Sold By: Authorized Medical Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 261 devices
Distributed To: Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.