Reported Jan 8, 2020 · Ongoing
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and…
Villa Sistemi Medicali S.P.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Villa Sistemi Medicali S.P.A. · Via delle Azalee 3 · Buccinasco, N/A · N/A
Is this the product you have?
- Juno DRF
- Model Number 709020 - Product UsageGeneral. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Lot codes and dates
- Serial Numbers
10110770110308051103080611070845110708481107084911110900120209781202098212030999120410031206101412061018120610201208104012091074121011041212118612121187130312151310126314021301140313131404132114051332140713531408135914091368140913711412140014121403150214261503144015041444150914731509147815101484151014871512150516011512160215141602151716021518160415331612159519011923
- Serial Numbers
- Amount recalled
- 46
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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