FDA Devices recall · Reported August 12, 2026
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 sys
Due to a defective circuit board that overheats
Oxos Medical Inc recalled Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Num… - a moderate-severity action.
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Num… was recalled by Oxos Medical Inc in August 12, 2026. Reason: Due to a defective circuit board that overheats. Check the official notice for the remedy. Verify recall #Z-2857-2026 with the FDA Devices before acting.
The recall
Oxos Medical Inc issued this moderate-severity FDA Devices recall-Due to a defective circuit board that overheats.
- Moderate
- severity level
- 77 units
- affected scope
- Class II
- classification
- August 12, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2857-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Reason for recall
Due to a defective circuit board that overheats
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2857-2026 |
| Date reported | August 12, 2026 |
| Date initiated | June 11, 2026 |
| Recalling firm | Oxos Medical Inc |
| Firm location | Atlanta, GA |
| Affected scope | 77 |
| Distribution | US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2857-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026