Villa Sistemi Rotograph EVO 3D X-ray recall
Villa Sistemi Rotograph EVO 3D X-ray
Why was Villa Sistemi Rotograph EVO 3D X-ray recalled?
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
p/n 9307251291, 9307351291, 9307651291
- Product
- Villa Sistemi Rotograph EVO 3D X-ray
- Recalling firm
- Villa Radiology Systems LLC
- Quantity
- Rotograph EVO 3D - 8 installed
- Distribution
- US Distribution
- Recall date
- November 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)