Z-0128-2016Class II

Villa Sistemi Rotograph EVO 3D X-ray

Name: Z-0128-2016 Villa Sistemi Rotograph EVO 3D X-ray
Creator: Villa Radiology Systems LLC
Published: 2015-08-05
License: https://open.fda.gov/license/

Acteon, Inc. / initiated 2015-08-05 / Terminated

FDA source

Villa Radiology Systems LLC began a recall of Villa Sistemi Rotograph EVO 3D X-ray on 2015-08-05. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0128-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-05
Posted: 2015-11-06
Terminated: 2017-03-22
Recalling firm: Acteon, Inc.
Product: Villa Sistemi Rotograph EVO 3D X-ray
Product code: MUH System, X-Ray, Extraoral Source, Digital
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).
FDA root cause: Other
Action: Villa Radiology Systems Planned Action: 1. The current users manuals have been updated and addendums to the user manuals have been developed for currently installed Rotograph Evo 3D and Imax Touch 3D. The revisions and addendums contain all information required under 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and 1020.33(j). 2. New Rotograph Evo 3D and Imax Touch 3D systems will ship with the updated user manual. 3. Addendums will be provided to all end users CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22.
Quantity in commerce: Rotograph EVO 3D - 8 installed
Distribution: US Distribution
Product codes and lots: p/n 9307251291, 9307351291, 9307651291

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0128-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0128-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06
Z-0129-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code MUH

K111152Class IIRotograph Evo 3DVilla Sistemi Medicali S.P.A. / cleared 2011-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)