Z-2857-2026Class II

Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1...

Name: Z-2857-2026 Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1...
Creator: Oxos Medical Inc
Published: 2026-06-11
License: https://open.fda.gov/license/

Oxos Medical Inc / initiated 2026-06-11 / Open, Classified

FDA source

Oxos Medical Inc began a recall of 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... on 2026-06-11. FDA classified it as Class II and gives the reason as "Due to a defective circuit board that overheats". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2857-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-11
Posted: 2026-08-03
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to a defective circuit board that overheats
FDA 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 [email protected].
Quantity in commerce: 77
Distribution: US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2857-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2857-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03

Product code OWB

K252068Class IIMC2 Portable X-ray SystemOxos Medical / cleared 2025-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)