Danvers, MA, United States
NeuroLogica Corporation recalls
10 recalls recorded since 2018, most recently on 7 October 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls10
Ongoing (FDA)5
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 October 2025
- Reason
- 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.
- Distribution
- Domestic: US Nationwide Distribution. International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Saudi Ara
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0480-2026
- GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Ongoing Class II Medical devices
- Recall started
- 8 July 2024
- Reason
- Potential for the anti-fall system of the device arm to fail.
- Distribution
- US Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2715-2024
- GM60A. Digital Diagnostic Mobile X-Ray System.
Ongoing Class II Medical devices
- Recall started
- 28 December 2023
- Reason
- Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
- 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, TN, TX, VA, WI & WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1056-2024
- Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Ongoing Class II Medical devices
- Recall started
- 6 June 2023
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2068-2023
- 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
Ongoing Class II Medical devices
- Recall started
- 8 March 2023
- Reason
- 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
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1414-2023
- Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Terminated Class II Medical devices
- Recall started
- 15 July 2020
- Terminated
- 13 July 2021
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2772-2020
- OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be
Terminated Class II Medical devices
- Recall started
- 25 July 2019
- Terminated
- 11 September 2020
- Reason
- 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.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2276-2019, Z-2275-2019
- 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, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.
- 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, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
Terminated Class II Medical devices
- Recall started
- 6 May 2019
- Terminated
- 10 June 2020
- Reason
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1691-2019
- Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technicia
Terminated Class II Medical devices
- Recall started
- 12 January 2018
- Terminated
- 14 August 2018
- Reason
- 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.
- Distribution
- US Distribution . Only one consignee was shipped 16 units of the affected device.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1391-2018
- Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Terminated Class II Medical devices
- Recall started
- 22 June 2017
- Terminated
- 5 October 2018
- Reason
- An image was obtained with over exposure during a Thorax examination using the AEC function.
- Distribution
- Nationwide US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0726-2018
- The GC80 Digital X-ray Imaging System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.