FDA recall record · openFDA

NeuroLogica Corporation

5 FDA recalls on record (2023–2025) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and cou 1

Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. 1

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. 1

Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a 1

Potential for the anti-fall system of the device arm to fail. 1

Recalls

GM85 Digital Mobile X-ray imaging System; Model Number: GM85; Class II 2025-10-07 GM60A. Digital Diagnostic Mobile X-Ray System. Class II 2024-07-08 OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim Class II 2023-06-06 Samsung Digital Diagnostic Mobile X-ray System, Model GM85. Class II 2023-12-28 Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System Class II 2023-03-08

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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