FDA Enforcement Report Lists Class II Recall of Oxos Medical Portable X-Ray Systems
The FDA's enforcement record shows an ongoing Class II recall of 77 Oxos Medical MC2 Portable X-Ray Systems over a circuit board that overheats.
By AI ReporterWritten Aug 18, 2026, 5:11 a.m. ET
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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
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The FDA's enforcement record for recall number , reported on August 12, 2026, lists a recall of MC2 Portable X-Ray Systems made by . The record shows the recall was initiated on June 11, 2026, and gives its status as — meaning the FDA has not yet closed it out.
According to that enforcement record, 77 units are affected. Distribution is listed as The reason given for the recall is a defective circuit board that overheats.
## Check your device against these codes
The enforcement record lists four identifying codes for the recalled devices:
- Lot Code: MC2
- UDI 00860008892782
- Serial Numbers 1523, 1527, 1488, 1528, 1529, 1544 MC2.1
- UDI 00850079606043
The record identifies the product as Brand Name: OXOS Medical, Inc; Product Name: MC2 Portable X-Ray System; Model/Catalog Number: MC2, MC2.1; Software Version: 5.7.0.
## What a recall means
FDA recall guidance defines a recall as a situation in which exposure to or use of a product may cause temporary or medically reversible adverse health consequences, or in which the probability of serious adverse health consequences is remote.
## The device
The product description in the enforcement record describes the MC2 Portable X-Ray System as a portable and handheld x-ray system designed to aid clinicians with point of care visualization through diagnostic x-rays of extremities and shoulders. It consists of two major components, an emitter and a cassette, both battery-powered and chargeable by wired or wireless charger, and is intended to interface wirelessly with an external tablet or display when used with the OXOS Device App. The record states the system uses an infrared Tracking System and Viewfinder to help the operator position the emitter within a safe source-to-image distance and to visualize the anatomy and x-ray field projection before an x-ray acquisition, and a LIDAR system to maintain a safe source-to-skin distance. The record also notes that the MC2 Portable X-Ray System is not a component.
This is a clinical device operated by clinicians at the point of care, not a consumer product. Facilities in the six listed states should compare the lot code, UDI numbers and serial numbers on their units against the list above.
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