Facility

VILLA SISTEMI MEDICALI S.P.A.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002808461
Establishment type	Manufacture Medical Device
Location	VIA DELLE AZALEE 3 BUCCINASCO Milano, IT 20090
Registration status	Active · expires 2026
Parent company	Villa Sistemi Medicali S.p.A. (owner-operator 9027610)
Brand names	Apollo EZ DRF; Apollo EZ; Apollo; Apollo DRF

Activity by year

Recalls (2)

Devices registered here (3)

Device, Spot-Film
Product code IXL (opens in a new tab) · Class II · Radiology · 21 CFR 892.1670
Device, Beam Limiting, X-Ray, Diagnostic
Product code KPW (opens in a new tab) · Class II · Radiology · 21 CFR 892.1610
Table, Radiologic
Product code KXJ (opens in a new tab) · Class II · Radiology · 21 CFR 892.1980

Recalls & enforcement

Class IIOngoing2019-11-04
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 bef…
Class IITerminated2016-12-27
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.

All facilities operated by Villa Sistemi Medicali S.p.A.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “VILLA SISTEMI MEDICALI S.P.A. (FEI 3002808461) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808461-villa-sistemi-medicali-s-p-a/

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