FDANovember 4, 2019device
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
villa sistemi medicali s p avillavilla sistemi
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAConnie's Classic Thin Crust Cheese Pizza, Chicago's Finest. Net Wt 20.36 oz. (1lb 4.36 oz) 577g. UPC 0 75706-19104 8. Keep Refrigerated. Distributed by: Palermo Villa, nc. Milwaukee, WI 53208.2024-12-11
- FDAArepas La Mejor, Arepa de Chocolo (Chocolate Sweet Corn Pancakes), NET WT. 25 Oz., 5 units per package, KEEP REFRIGERATED2024-06-06
- FDAApollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. ...2019-11-04
- FDAApollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-co...2019-11-04
- FDAApollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-co...2019-11-04
- FDAApollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.2016-12-27
- FDAJuno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures2016-12-27
- FDAApollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures2016-12-27
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