Villa Radiology Systems Recalls 3D X-ray Units for Documentation Deficiencies
Villa Radiology Systems LLC is recalling eight Rotograph EVO 3D X-ray units because accompanying documents are missing, causing non-compliance with FDA regulations.
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 issues and packaging-only problems (missing information documents) with no reported injuries or illnesses.
Plain-English summary
Villa Radiology Systems LLC is recalling eight units of the Villa Sistemi Rotograph EVO 3D X-ray device. The recall was initiated because the products lack necessary accompanying information documents, resulting in a failure to comply with 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and 1020.330.
The affected units are identified by part numbers 9307251291, 9307351291, and 9307651291. The source text indicates that these units were distributed in the United States.
This recall addresses regulatory compliance issues regarding documentation rather than a reported mechanical defect or safety hazard. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Villa Sistemi Rotograph EVO 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 (3)
- p/n 9307251291
- 9307351291
- 9307651291
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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