Reported Nov 18, 2015 · Terminated
Villa Sistemi Rotograph EVO 3D X-ray
Villa Radiology Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Villa Radiology Systems LLC · 91 Willenbrock Rd Ste B1 · Oxford, CT · 06478-1036
Is this the product you have?
- Villa Sistemi Rotograph EVO 3D X-ray
- Lot codes and dates
p/n 930725129193073512919307651291
- Amount recalled
- Rotograph EVO 3D - 8 installed
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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