Facility

Metaltronica Spa

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

Key facts

11recalls · 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)	3009868110
Establishment type	Manufacture Medical Device
Location	Pomezia (RM) via delle Monachelle 66 Pomezia Roma, IT 00071
Registration status	Active · expires 2026
Parent company	SEDECAL S.A. (owner-operator 9039772)
Brand names	Helianthus; Serenys DR

Activity by year

Recalls (11)

Devices registered here (1)

Full Field Digital, System, X-Ray, Mammographic
Product code MUE (opens in a new tab) · Class II · Radiology · 21 CFR 892.1715

Recalls & enforcement

Class IIOngoing2025-06-10
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Class IIOngoing2024-01-22
Potential interference with the anti-fall system.
Class IIOngoing2023-12-13
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Class IIOngoing2023-05-23
There is a software login in issue that may prevent the user from logging in.
Class IIOngoing2023-02-06
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Class IIOngoing2022-08-12
Due to un-commanded movement of mobile x-ray unit.
Class IIOngoing2021-10-14
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on i…
Class IIOngoing2018-07-18
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
Class IITerminated2016-01-18
This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwan…
Class IITerminated2015-07-13
Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause th…
Class IITerminated2014-08-06
Reports of unexpected movement.

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. “Metaltronica Spa (FEI 3009868110) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009868110-metaltronica-spa/

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