Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version:
FDA device recall Z-2857-2026 · posted 2026-08-03 · Open, Classified
Recall details
- Recalling firm
- Oxos Medical Inc
- Reason for recall
- Due to a defective circuit board that overheats
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 77
- Distribution
- US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA.
- Date initiated
- 2026-06-11
- Date posted
- 2026-08-03
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MC2 Portable X-ray System (K252068) | Oxos Medical | 2025-12-22 |