NeuroLogica Corporation recall records

5 reported ongoing

5 records in this archive. Latest source date Oct 7, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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

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.

Class IIReported ongoing

Distribution: Domestic: US Nationwide Distribution. International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungar...

Official source for GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
FDA device enforcement

Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.

Class IIReported ongoing

Distribution: US Nationwide Distribution including states of: AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SD, T...

Official source for Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
FDA device enforcement

OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000

1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the abil...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.

Official source for OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in t...

Reasons in these listed records

  • 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.
  • Potential for the anti-fall system of the device arm to fail.
  • Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
  • 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the ...

These examples come from this result page and are not a ranking of every recall reason.

Checking NeuroLogica Corporation

Is there a recall on neurologica corporation right now?

This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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