Reported Nov 19, 2025 · Ongoing

GM85 Digital Mobile X-ray imaging System; Model Number: GM85;

NeuroLogica Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NeuroLogica Corporation · 14 Electronics Ave · Danvers, MA · 01923-1011

Is this the product you have?

  • GM85 Digital Mobile X-ray imaging System
  • Model NumberGM85
Lot codes and dates
  • Model NumberGM85
  • UDI-DI08806088582412
  • Serial Numbers

    236 of 236 codes

    • 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
    • 513YM3IK500002R
    • 5143M3JK100005D
    • 5143M3IJ600004F
    • 5143M3IHC00005J
    • 5143M3JJC00004Y
    • 5143M3HK600003R
    • 5143M3JK500004D
    • 5143M3HK600004A
    • 5143M3HK300012L
    • 5143M3HK300008M
Amount recalled
236 units

Where it was sold

  • Nationwide

Why it was recalled

The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.