FDA Device recall Z-0763-2020
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy…
- FDA Device
- Class II
- ongoing
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy… by Villa Sistemi Medicali S P A, citing an amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0763-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-04 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Villa Sistemi Medicali S P A |
| Distribution | US |
Product
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Reason
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Identifiers
| code_info | Serial Numbers: 10110770 11030805 11030806 11070845 11070848 11070849 11110900 12020978 12020982 12030999 120…Serial Numbers: 10110770 11030805 11030806 11070845 11070848 11070849 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 19011923 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0763-2020%22
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