FDA Medical Device Recalls (openFDA)
Villa Radiology Systems LLC: Juno DFR X-ray system
- Recall number
- Z-1079-2015
- Recalling firm
- Villa Radiology Systems LLC
- Product
- Juno DFR X-ray system
- Status
- Terminated
- Initiated
- 2014-12-14
- Posted
- 2015-03-06
- Terminated
- 2017-03-16
- Reason
- The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Planned Action by the firm: 1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge. 2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan 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 The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015. For further questions please 203.262-8836
- Quantity
- 30 units distributed in the US
- Distribution
- US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
- Lot, serial or model codes
- P/N 709020
- 510(k) numbers
- ["K050190"]
- PMA numbers
- not on file
- Product code
- KXJ
- 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