Villa Radiology Systems Recalls Owandy I-MAX Touch 3D X-ray Units
Villa Radiology Systems LLC is recalling six Owandy Radiology I-MAX Touch 3D X-ray units because they lack required accompanying information documents.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves documentation and labeling compliance issues (missing information documents) rather than a physical defect or health hazard, consistent with the rubric for documentation issues.
Plain-English summary
Villa Radiology Systems LLC is recalling six installed Owandy Radiology I-MAX Touch 3D X-ray units. The recall affects units with part numbers 9306251191 and 9306651191 that were distributed in the United States.
The recall was initiated because the products fail to comply with 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and 1020.330 due to a lack of information accompanying documents. This is a documentation and labeling compliance issue rather than a mechanical defect or safety hazard.
Consumers and healthcare facilities with these specific units should contact Villa Radiology Systems LLC for further instructions on how to obtain the required documentation.
The recalled product
- Product
- Owandy Radiology I -MAX Touch 3D X-ray
- Manufacturer
- Villa Radiology Systems LLC
- Hazard
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 (1)
- p/n 9306251191 and 9306651191
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Villa Radiology Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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