Villa Sistemi recalls Juno DRF model 709020 x-ray systems due to potential angulation chain failure after 8 years of use, risking metal fatigue under heavy workload.
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.
Villa Sistemi is recalling Juno DRF x-ray systems with model number 709020 because the angulation chain may fail earlier than expected due to metal fatigue after 8 years of use. This could lead to system malfunction during medical procedures.
The angulation chain in these x-ray systems may break due to metal fatigue after 8 years of use, especially under heavy workload conditions. This could cause the system to malfunction during medical imaging procedures, potentially affecting patient safety.
Medical facilities using the Juno DRF model 709020 x-ray systems with serial numbers listed in the recall notice are most at risk. Patients and staff during radiography procedures could be affected if the system malfunctions.
Check for the model number 709020 on the Juno DRF x-ray system. The recall includes specific serial numbers listed in the notice, which are provided in the official recall document.
Verify if your x-ray system has been in use for 8 years or more.
Reach out to Villa Sistemi Medicali S.P.A. for guidance on the replacement of the angulation chain.
The recall states that after 8 years of service, the angulation chain may fail due to metal fatigue under heavy workload conditions, requiring replacement before the expected 10-year lifetime.
The recall indicates that the angulation chain might fail before the expected 10-year lifetime, potentially causing system malfunction during medical procedures.
No, the recall does not require immediate stoppage; the manufacturer recommends checking the system age and contacting them for replacement guidance.
We’ve drafted a message you can send Villa Sistemi to request your refund or repair — edit it as you like.
Subject: Recall Z-0763-2020 — Villa Sistemi Villa Sistemi Hello, I own a Villa Sistemi that is covered by recall Z-0763-2020 from Villa Sistemi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
