Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Versi
Summary
The FDA issued a Class II for Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Ca by Oxos Medical Inc. Reason: Due to a defective circuit board that overheats.
Details
Source
Device Recall
External ID
Z-2857-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 77
Reason for Recall
Due to a defective circuit board that overheats
Distribution
US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-11
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Oxos Medical Inc has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oxos Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oxos Medical Inc have FDA actions?
Oxos Medical Inc has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2857-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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