NeuroLogica Corporation FDA Recalls

5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;Class IIOct 7, 2025The four (4) M5 bolts that secure the Tube Head Unit to the	The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal	Class IIDevices	Oct 7, 2025
GM60A. Digital Diagnostic Mobile X-Ray System.Class IIJul 8, 2024Potential for the anti-fall system of the device arm to fail	Potential for the anti-fall system of the device arm to fail.	Class IIDevices	Jul 8, 2024
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.Class IIDec 28, 2023Mobile x-ray systems moving arm frame welding issue which pr	Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of	Class IIDevices	Dec 28, 2023
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primClass IIJun 6, 20231. Wheels loosening over time with use of the device could l	1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the devi	Class IIDevices	Jun 6, 2023
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray SystemClass IIMar 8, 2023Issue related to the operation of the arm latch within the c	Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm	Class IIDevices	Mar 8, 2023