Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Chain Failure
Villa Sistemi Medicali is recalling 46 Juno DRF x-ray systems because the angulation chain may fail early due to metal fatigue.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical component failure in a medical device that could lead to equipment malfunction, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Villa Sistemi Medicali S.P.A. is recalling 46 units of the Juno DRF, Model Number 709020, multi-function x-ray systems. These systems are used for routine radiographs and general fluoroscopy procedures.
The recall was issued because testing revealed that the angulation chain might fail before its expected lifetime of 10 years. This potential failure is attributed to metal fatigue under severe workload conditions. An amendment to the Instructions for Use and Service Manual has been issued to prescribe the replacement of the angulation chain after 8 years of service.
The affected units were distributed nationwide in the United States, including the District of Columbia and Puerto Rico. Specifically, distribution occurred in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico. Users should check their serial numbers against the provided list to determine if their unit is affected.
The recalled product
- Product
- Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
- Manufacturer
- Villa Sistemi Medicali S.P.A.
- Category
- Medical Device — X-Ray Systems
- Hazard
- Affected units
- 46
Distribution
Part of a larger recall action
This product is one of 4 recalled by Villa Sistemi Medicali S.P.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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