Oxos Medical Inc: Interventional Fluoroscopic X-ray System
Recall Summary Oxos Medical is recalling the MC2 Portable X-Ray System (models MC2 and MC2.1, software version 5.7.0) due to a defective circuit board that can overheat. The MC2 is a handheld x-ray device used by clinicians to take diagnostic images of extremities and shoulders. The recall affects devices distributed nationwide across multiple states.
- 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...
- Reason
- Due to a defective circuit board that overheats
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/16c59669-f4fc-4fe8-9a8c-d503858d9e62