NeuroLogica Recalls
13 recalls on record · November 18, 2015 to November 19, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 19, 2025Medical DevicesFDA
NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Hazard: 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.
August 28, 2024Medical DevicesFDA
NeuroLogica Corporation recalls GM60A. Digital Diagnostic Mobile X-Ray System.
Hazard: Potential for the anti-fall system of the device arm to fail.
February 21, 2024Medical DevicesFDA
NeuroLogica Corporation recalls Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Hazard: Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
July 12, 2023Medical DevicesFDA
NeuroLogica Corporation recalls OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim
Hazard: 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 device, this could lead to delay for patient treatment
April 26, 2023Medical DevicesFDA
NeuroLogica Corporation recalls Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Hazard: Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
August 19, 2020Medical DevicesFDA
NeuroLogica Corporation recalls OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Produ
Hazard: There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.
August 21, 2019Medical DevicesFDA
NeuroLogica Corporation recalls WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.
Hazard: There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
August 21, 2019Medical DevicesFDA
NeuroLogica Corporation recalls HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.
Hazard: There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
June 5, 2019Medical DevicesFDA
NeuroLogica Corporation recalls Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended f
Hazard: Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
April 25, 2018Medical DevicesFDA
NeuroLogica Corporation recalls Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Hazard: While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
March 14, 2018Medical DevicesFDA
NeuroLogica Corporation recalls The GC80 Digital X-ray Imaging System
Hazard: An image was obtained with over exposure during a Thorax examination using the AEC function.
September 6, 2017Medical DevicesFDA
NeuroLogica Corporation recalls Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human ana
Hazard: When performing the Stitching function on GU60A system, unintended area is exposed to radiation
November 18, 2015Medical DevicesFDA
NeuroLogica Corporation recalls Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Hazard: When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.