FDA Medical Device Recalls (openFDA)
Villa Sistemi Medicali S.P.A.: Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Recall number
- Z-1427-2017
- Recalling firm
- Villa Sistemi Medicali S.P.A.
- Product
- Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Status
- Terminated
- Initiated
- 2016-12-27
- Posted
- not on file
- Terminated
- 2021-03-09
- Reason
- Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
- Root cause
- Nonconforming Material/Component
- Action
- Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken.
- Quantity
- 65 devices in total
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I
- Lot, serial or model codes
- Serial Numbers: 10110770 11030805 11070845 11070848 11070849 11090864 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487 15121505 16011512 16021514 16021517 16021518 16041533 16121595
- 510(k) numbers
- ["K050190"]
- PMA numbers
- not on file
- Product code
- KXJ
- Firm FEI
- 3002808461
- Firm city
- Buccinasco
- Firm state
- not on file
- Firm country
- Italy
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