CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
Villa Sistemi Rotograph EVO 3D X-ray recalled by Villa Radiology Systems
Villa Radiology Systems is recalling Villa Sistemi Rotograph EVO 3D X-ray. The recall was initiated on 5 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0128-2016
- FDA event ID
- 71958
- Recalling firm
- Villa Radiology Systems, Oxford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Aug 2015
- FDA classified
- 6 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 5 Aug 2015 | Recall initiated by company | |
| 6 Nov 2015 | Classified by FDA | +93 days |
| 18 Nov 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Product as listed by the FDA
Villa Sistemi Rotograph EVO 3D X-ray
Where it was distributed
US Distribution
Questions about this recall
Why was it 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).
Which lots are affected?
p/n 9307251291, 9307351291, 9307651291
Where was it sold?
US Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71958This product is part of a recall event; the main page for the event is Owandy Radiology I -MAX Touch 3D X-ray recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Owandy Radiology I -MAX Touch 3D X-ray recalled | Villa Radiology Systems | Other | CT |
More recalls from Villa Radiology Systems
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Apollo EZ recalled by Villa Radiology Systems | Villa Radiology Systems | Other | 24 states |
| Device | CLASS II | Apollo DRF recalled by Villa Radiology Systems | Villa Radiology Systems | Other | 24 states |
| Device | CLASS II | Juno DRF recalled by Villa Radiology Systems | Villa Radiology Systems | Other | 24 states |
| Device | CLASS II | Apollo: Models: 9784000131 recalled by Villa Radiology Systems | Villa Radiology Systems | Other | 24 states |
| Device | CLASS II | Owandy Radiology I -MAX Touch 3D X-ray recalled | Villa Radiology Systems | Other | CT |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |