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Terminated

Owandy Radiology I -MAX Touch 3D X-ray

FDA Recall Z-0129-2016 · Posted 2015-11-06

Recalling FirmVilla Radiology Systems LLC
Recall StatusTerminated
Product CodeOAS
Date Initiated2015-08-05
Date Terminated2017-03-22
Product QuantityI-MAX Touch 3D- 6 installed

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).

Firm 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.

Root Cause

Other

Distribution Pattern

US Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130443I-MAX TOUCH 3DOwandy · 2013-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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