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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: Digital Mobile X-Ray Systems Recalled for Potential Fall Risk

Agency Publication Date: August 22, 2024
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Summary

NeuroLogica Corporation is recalling 31 units of the GM60A Digital Diagnostic Mobile X-Ray System because the anti-fall system on the device arm may fail. This mobile medical imaging device is used in various healthcare settings to take diagnostic X-rays. If the anti-fall mechanism fails, the heavy X-ray arm could drop unexpectedly, posing a physical danger to both patients and healthcare operators. Consumers should check their device serial numbers to see if their unit is part of the affected batch distributed across several U.S. states and the District of Columbia.

Risk

The anti-fall system, designed to prevent the X-ray arm from falling during use or transport, may malfunction or fail. This creates a mechanical hazard where the arm could collapse or drop, potentially striking a patient or staff member, causing impact injuries.

What You Should Do

  1. Identify if your device is affected by checking the Serial Number on the GM60A Digital Diagnostic Mobile X-Ray System unit. Affected Serial Numbers include: G69812, G69821, G69824, G69986, G69987, G71422, G71425, G71431, G71434, G71795, G71798, G71802, G72052, G72053, G72264, G72279, G72296, G72301, G72310, G72313, G72319, G72320, G72481, G72484, G72595, G72601, G72853, G72875, G73179, G73184, and G73542.
  2. Verify the Samsung Serial Number and UDI on the device label. Affected UDI numbers are 08806088511153 or 08806088088266.
  3. Contact your healthcare provider or NeuroLogica Corporation directly for further instructions regarding a potential inspection or repair of the anti-fall mechanism.
  4. For additional questions, contact the FDA medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall notification via E-Mail.

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

Affected Products

Product: GM60A Digital Diagnostic Mobile X-Ray System
Model / REF:
G69812
G69821
G69824
G69986
G69987
G71422
G71425
G71431
G71434
G71795
G71798
G71802
G72052
G72053
G72264
G72279
G72296
G72301
G72310
G72313
G72319
G72320
G72481
G72484
G72595
G72601
G72853
G72875
G73179
G73184
G73542
Lot Numbers:
Samsung SN: 50WFM9BG900003M
Samsung SN: 50WFM9BG900004J
Samsung SN: 50WFM9BG900005H
Samsung SN: 50WFM9BGA00001T
Samsung SN: 50WFM9BGA00002B
Samsung SN: 50WFM9BH300001E
Samsung SN: 50WFM9BH300002W
Samsung SN: 50WFM9BH300003Z
Samsung SN: 50WFM9BH300004N
Samsung SN: 50WFM9BH400001X
Samsung SN: 50WFM9BH400002W
Samsung SN: 50WFM9BH400003A
Samsung SN: 50WFM9BH500001H
Samsung SN: 50WFM9BH500002Y
Samsung SN: 50WFM9BH600001P
Samsung SN: 50WFM9BH600002L
Samsung SN: 50WFM9BH600003F
Samsung SN: 50WFM9BH600004Y
Samsung SN: 50WFM9BH600005W
Samsung SN: 50WFM9BH600006N
Samsung SN: 50WFM9BH600007K
Samsung SN: 50WFM9BH600008J
Samsung SN: 50WFM9BH700002B
Samsung SN: 50WFM9BH700001P
Samsung SN: 50WFM9BH700003M
Samsung SN: 50WFM9BH700004E
Samsung SN: 50WFM9BH800002E
Samsung SN: 50WFM9BH800003D
Samsung SN: 50WFM9BH900001X
Samsung SN: 50WFM9BH900002D
Samsung SN: 50WFM9BHB00001T

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95100
Status: Active
Manufacturer: NeuroLogica Corporation
Sold By: NeuroLogica Corporation
Manufactured In: United States
Units Affected: 31 units
Distributed To: Arkansas, Connecticut, Georgia, Indiana, Kansas, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, Ohio, Pennsylvania, Virginia, West Virginia, District of Columbia

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.