Oxos Medical Inc — Class II: Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Numb
Oxos Medical Inc has initiated a Class II recall for the MC2 Portable X-Ray System (Models MC2 and MC2.1, Software Version 5.7.0) due to a defective circuit board that is prone to overheating.
This recall affects clinical operators using portable x-ray systems for extremity and shoulder imaging, as well as biomedical engineering and regulatory departments responsible for the maintenance and compliance of these handheld diagnostic devices.
The failure of a primary hardware component (circuit board) causing overheating presents both device reliability and potential safety risks in a handheld configuration. Regulatory and engineering teams will likely need to investigate the root cause of the board defect and assess if the current software version or charging configuration contributes to the thermal issue. The ongoing status suggests that remediation or hardware replacement protocols are still in progress.
QA and engineering teams should verify if currently deployed MC2 units (Software 5.7.0) are within the affected lot range and isolate devices pending repair. Facilities utilizing these portable systems should monitor for overheating signs and ensure staff are aware of the hardware defect related to the circuit board.
Class II. Reason: Due to a defective circuit board that overheats. Product: Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with point of care visualization through diagnostic x-rays of extremities and shoulders. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and can be charged with either a wired or wireless charger. The system is intended to interface wirelessly to an external tablet or display when used with the OXOS Device App. The MC2 utilizes an infrared Tracking System and Viewfinder that allows the operator to position the emitter within a safe source-to-image distance (SID) and allows the operator to visualize the anatomy and x-ray field projection prior to initiating an x-ray acquisition. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance. Component: The MC2 Portable X-Ray System is not a component.. Firm: Oxos Medical Inc (Atlanta GA United States). Status: Ongoing.
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