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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 GM85 Digital Mobile X-ray Systems Recalled for Loosening Bolts

Agency Publication Date: November 7, 2025
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Summary

NeuroLogica Corporation has recalled 236 units of the GM85 Digital Mobile X-ray imaging System. The recall was initiated because the four M5 bolts that secure the Tube Head Unit to the supporting arm can loosen or break over time due to metal fatigue. If these bolts fail, the heavy X-ray imaging head could potentially detach or move unexpectedly.

Risk

Metal fatigue in the attachment bolts could cause the X-ray tube head to become unstable or fall, posing a serious risk of physical injury to both patients and healthcare personnel.

What You Should Do

  1. This recall affects GM85 Digital Mobile X-ray imaging Systems manufactured by NeuroLogica Corporation.
  2. Check the serial number on the device label to determine if your unit is included in this recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: GM85 Digital Mobile X-ray imaging System
Model / REF:
GM85
Serial Numbers (236):
514GM3IK400001L
5143M3IK300001X
5143M3IJ100010M
5143M3IHC00014H
5143M3IK300008R
5143M3JJ400007E
5143M3HJ900002V
5143M3IK400004F
513YM3IK500003Z
5143M3HK600005V
5143M3JJ200010J
5143M3HK600008M
5143M3HK200004H
5143M3JK500003W
5143M3IJ200002F
5143M3IHC00007A
5143M3JJ300001K
5143M3IJ600014H
5143M3JK500006X
5143M3JJ200017Y
5143M3JK400014E
5143M3IJ600013B
5143M3GK500004A
5143M3IHC00011V
5143M3JK500001M
5143M3JJ300012N
5143M3GK500005M
5143M3IK400007W
5143M3JK400008N
5143M3JJ300011Z
5143M3JK100003Z
5143M3JK500007L
5143M3IK500001F
5143M3IHC00002L
5143M3IK300006T
5143M3IHC00010R
5143M3IK600004K
5143M3IJ300003E
5143M3IHC00003Y
5143M3JJ400006K
5143M3HJ900001L
5143M3IJ600003L
5143M3IJC00001Y
5143M3IJ600001H
5143M3HJ500003A
5149M3IK400003E
5143M3IJ800008L
5143M3JJ700002R
5143M3HK300002V
5143M3JJ200008B
UDI:
08806088582412

Quantity affected: 236 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97721
Status: Active
Manufacturer: NeuroLogica Corporation
Sold By: Medical facilities; Hospitals
Manufactured In: United States
Units Affected: 236 units
Distributed To: Nationwide

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.