NeuroLogica Corporation recalls Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
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
Read the official notice →- Date
- 2023-04-26
- Country
- United States
- Brand
- NeuroLogica
- Product
- Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More NeuroLogica recalls
- 2025-11-19
USNeuroLogica Corporation recalls 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.
FDA · DeviceNeuroLogica CorporationDomestic: US Nationwide Distribution. International: Australia, Belgium,…Official notice →- 2024-08-28
- US
NeuroLogica Corporation recalls GM60A. Digital Diagnostic Mobile X-Ray System.
Potential for the anti-fall system of the device arm to fail.
FDA · DeviceNeuroLogica CorporationUS Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO,…Official notice → - 2024-02-21
- US
NeuroLogica Corporation recalls 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.
FDA · DeviceNeuroLogica CorporationUS Nationwide Distribution including states of: AL, AR, CA, CO, CT, DC, FL,…Official notice → - 2023-07-12
- US
NeuroLogica Corporation recalls OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and…
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…
FDA · DeviceNeuroLogica CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →
Other drugs & medical recalls in the United States
- 2023-04-26
- US
Olympus Corporation of the Americas recalls Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model…
There have been complaints that the clip did not come out of the tube sheath during the procedure.
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - US
Becton Dickinson & Co. recalls BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro…
Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a…
FDA · DeviceBecton Dickinson & Co.Worldwide - US Nationwide distribution in the states of IL, NY and the…Official notice → - US
Medtronic Sofamor Danek USA Inc recalls INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and…
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Medtronic Neuromodulation recalls Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of…
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
The CirClamp subassembly found in the kit was the incorrect size.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CA and TX. There was no…Official notice →