Class II — Oxos Medical Inc
| Recalling firm | OXOS Medical, Inc |
|---|---|
| Registered facility | OXOS MEDICAL, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to a defective circuit board that overheats |
| 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 c… |
| Quantity | 77 |
| Distribution | US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA. |
| Initiated | 2026-06-11 |
| Classified | 2026-08-03 |
| Recall number | Z-2857-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Oxos Medical Inc (Z-2857-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99263/
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