DeviceSignal · Recall classified
Oxos Medical Inc
FDA classified a device recall on 2026-08-03 · Class II · Z-2857-2026
EventRecall classified
Effective2026-08-03
ClassificationClass II
On 2026-08-03 the FDA classified a device recall from Oxos Medical Inc as Class II. Product: Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog…. Recall Z-2857-2026. The firm initiated it on 2026-06-11. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2857-2026
- Classification
- Class II
- Classified on
- 2026-08-03
- Initiated on
- 2026-06-11
- Firm
- Oxos Medical Inc
- 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 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2857-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
65a19012657f13782eed60e92990f43925b6f9195fcf02132ebe61054df8dabf- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)