Data / Medical devices / Italy / Villa Sistemi Medicali S.P.A.

Villa Sistemi Medicali S.P.A.: FDA-registered device maker in BUCCINASCO Milano, Italy, 2 510(k) clearances

Name: Villa Sistemi Medicali S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Villa Sistemi Medicali S.P.A. is registered with the FDA (registration 8021091) in BUCCINASCO Milano, Italy. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 4, 2008. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8021091
FEI number: 3002808461
Address: Via Delle Azalee 3, BUCCINASCO Milano, Italy, 20090
Owner or operator: Villa Sistemi Medicali S.p.A. (9027610)
Roles: Manufacturer
First device listed: November 30, 2007
Registered through: 2026
Brand names listed: Apollo, Apollo DRF, Apollo EZ, Apollo EZ DRF, DRF 4343, DRF 4343 FL, DRF 4343-LT System DT, DRF 4343-TS

Devices it lists

Device	Product code	Class	Role	Source
Device, Beam Limiting, X-Ray, Diagnostic	KPW	2	Manufacturer	accessdata.fda.gov
Device, Spot-Film	IXL	2	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov
Table, Radiologic	KXJ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 4, 2008	K080859	DRF 4343	JAA	Substantially Equivalent	Villa Sistemi Medicali S.P.A.	accessdata.fda.gov
March 25, 2005	K050190	APOLLO	KXJ	Substantially Equivalent	Villa Sistemi Medicali S.P.A.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 4, 2019	84309	Class II	Ongoing	Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.	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.	accessdata.fda.gov
December 27, 2016	76367	Class II	Terminated	Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures	Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.	accessdata.fda.gov

Compare with other makers

Updated June 4, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.