Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0763-2020 — Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.

U.S. FDA — Device Enforcement · Italy · 2019-11-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0763-2020
Date of alert
2019-11-04
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Villa Sistemi Medicali S.P.A.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10110770
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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