Reported Aug 12, 2026 · Ongoing
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software…
Oxos Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oxos Medical Inc · 1100 Peachtree St Ne Ste 700 · Atlanta, GA · 30309-4516
Is this the product you have?
- Brand NameOXOS Medical
- Inc Product NameMC2 Portable
- X-Ray System Model/Catalog Number
MC2MC2.1
- Software Version5.7.0
- Product DescriptionThe 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 componentsthe 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
- ComponentThe MC2 Portable X-Ray System is not a component
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 Lot Code: MC2 2 00860008892782UDI 00860008892782 3 Serial Numbers 1523, 1527, 1488, 1528, 1529, 1544 MC2.1 4 00850079606043UDI 00850079606043 5 008600088927820086000889278200860008892782008600088927820086000889278200860008892782008500796060430085007960604300850079606043Serial 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 - Amount recalled
- 77
Where it was sold
Why it was recalled
Due to a defective circuit board that overheats
This product could cause temporary or reversible health problems — stop using it.
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