OXOS Medical Recalls MC2 Portable X-Ray Systems Over Circuit Board Overheating
OXOS Medical Inc is recalling 77 units of the MC2 Portable X-Ray System due to a defective circuit board that overheats. The recall affects devices distributed nationwide in FL, GA, IN, SC, TX, and VA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a defective circuit board that overheats in a medical device. Per the rubric, FDA Class II recalls with risk-of-harm products where injury has not yet been reported are scored as Severe (4).
Plain-English summary
OXOS Medical Inc is recalling 77 units of the MC2 Portable X-Ray System, including models MC2 and MC2.1 with software version 5.7.0. The recall is due to a defective circuit board that overheats, which poses a potential risk to the device's safe operation.
The affected devices were distributed nationwide in the states of Florida, Georgia, Indiana, South Carolina, Texas, and Virginia. Specific serial numbers and lot codes have been identified, including UDI codes and serial numbers such as 1523, 1527, 1488, 1528, 1529, 1544, 1461, 1462, and 1547.
Healthcare facilities and users who have been affected by this recall should immediately stop using the recalled devices and contact OXOS Medical Inc to arrange for a replacement or repair. The firm is working with the FDA to address the issue and ensure customer safety.
This is a Class II recall, meaning the device could cause temporary or medically reversible adverse health consequences, or where the probability of serious temporary adverse health consequences is not likely to be greater than the generally remote probability of serious permanent health consequences.
The recalled product
- 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…
- Manufacturer
- Oxos Medical Inc
- Affected units
- 77
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot Code: MC2
- UDI 00860008892782
- Serial Numbers 1523
- 1527
- 1488
- 1528
- 1529
- 1544 MC2.1
- UDI 00850079606043
- Serial Numbers: 1461
- 1462
Distribution
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