FDA Medical Device Recalls (openFDA)
Villa Radiology Systems LLC: Owandy Radiology I -MAX Touch 3D X-ray
- Recall number
- Z-0129-2016
- Recalling firm
- Villa Radiology Systems LLC
- Product
- Owandy Radiology I -MAX Touch 3D X-ray
- Status
- Terminated
- Initiated
- 2015-08-05
- Posted
- 2015-11-06
- Terminated
- 2017-03-22
- Reason
- 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).
- 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
- I-MAX Touch 3D- 6 installed
- Distribution
- US Distribution
- Lot, serial or model codes
- p/n 9306251191 and 9306651191
- 510(k) numbers
- ["K130443"]
- PMA numbers
- not on file
- Product code
- OAS
- Firm FEI
- 2243757
- Firm city
- Oxford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28