Oxos Medical Inc: 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.

Recall number

Z-2857-2026

Recalling firm

Oxos Medical Inc

Product

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.

Status

Open, Classified

Initiated

2026-06-11

Posted

2026-08-03

Terminated

not on file

Reason

Due to a defective circuit board that overheats

Root cause

Process change control

Action

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 support@oxos.com.

Quantity

77

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K252068"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3018077344

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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