Brand Name: OXOS Medical, Inc recallZ-2857-2026 · Oxos Medical Inc · initiated Jun 11, 2026

Why it was recalled

Due to a defective circuit board that overheats

FDA root cause category: Process change control

What the company is doing

On 06/12/2026, an "URGENT: Medical Device Recall - Limited to Specific MC2 Units" letter was emailed to customers informing them that, due to faulty circuit boards limited units may experience localized overheating. As a result the firm released a software update (version 5.7.0) which will place a unit in a safe state if boards fail. Customers are instructed to: 1. Update units to software version 5.7.0 via over-air updates. Note, it is important to apply the software update to continue using the MC2 units 2. In addition to the software update, OXOS will replace the defective components with the cassette as part of a scheduled procedure. The MC2 must be returned to OXOS headquarters for replacement of affected components. Servicing will coordinate with customers to minimized any inconvenience. 3. Customer need to acknowledge receipt of the recall communication and complete the software update by calling OXOS Support Team at 866-749-4229 to schedule a time to perform the updated by emailing support#oxos.com, or accepting the update on their devices. For questions or assistance - contact Support Team at 866-749-4229 or email [email protected].

Recall details

Recall number

Z-2857-2026

Status

Open, Classified

Initiated by the company

Jun 11, 2026

Posted by the FDA

Aug 3, 2026

Recalling firm

Oxos Medical Inc

Quantity

77

Product code

OWB

FDA submissions

K252068

Distribution

US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• MC2 Portable X-ray System MC2.1

  OXOS Medical, Inc. · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• MC2 Portable X-ray System

  OXOS Medical, Inc. · Interventional Fluoroscopic X-Ray System
  1 recall0 reports