Villa Sistemi Medicali S.P.A.: 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.

Agency Publication Date: December 31, 2019

Affected Products

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

Serial Numbers: 10110770 11030805 11030806 11070845 11070848 11070849 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487 15121505 16011512 16021514 16021517 16021518 16041533 16121595 19011923

Product: Apollo, 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. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.

Serial Numbers: 08020473 11100873 15041446

Product: Apollo 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-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.

Serial Numbers: 08090531 09090591 10040680 15051450 11020798 17011602 17041639

Product: Apollo 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-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.

Serial Numbers: 13101261

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84309

Status: Active

Manufacturer: Villa Sistemi Medicali S.P.A.

Manufactured In: Italy

Units Affected: 4 products (46; 3; 7; 1)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

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

Serial Numbers: 08020473 11100873 15041446

Serial Numbers: 08090531 09090591 10040680 15051450 11020798 17011602 17041639

Serial Numbers: 13101261