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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.

Class II
Recalling firm
Oxos Medical Inc
Reason for recall
Due to a defective circuit board that overheats
Affected products (lot / model / serial)
Lot Code: MC2; UDI 00860008892782; Serial Numbers 1523, 1527, 1488, 1528, 1529, 1544 MC2.1; UDI 00850079606043; Serial Numbers: 1461, 1462, 1547 Full UDI for affected devices: (01)00860008892782(11)260107(21)1523 (01)00860008892782(11)260129(21)1527 (01)00860008892782(11)260109(21)1488 (01)00860008892782(11)260123(21)1528 (01)00860008892782(11)260130(21)1529 (01)00860008892782(11)260227(21)1544 (01)00850079606043(11)260407(21)1461 (01)00850079606043(11)260407(21)1462 (01)00850079606043(11)260408(21)1547
Units affected
77
Distribution pattern
US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.
Firm location
Atlanta, GA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2857-2026
Recall initiated
June 11, 2026
FDA classification date
August 3, 2026
FDA report date
August 12, 2026
FDA event ID
99263
Last updated on HTM Vibe
August 18, 2026
View on openFDA