Facility

SWISSRAY Medical, AG

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

Key facts

3recalls · 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)	3002143662
Establishment type	Repack or Relabel Medical Device
Location	TURBISTRASSE 25-27 HOCHDORF Luzern, CH CH 6280
Registration status	Active · expires 2026
Parent company	Swissray Medical AG (owner-operator 9003721)
Brand names	ddrAura (TM) Series

Activity by year

Recalls (3)

Devices registered here (1)

System, X-Ray, Stationary
Product code KPR (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680

Recalls & enforcement

Class IITerminated2018-11-14
A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to over…
Class IIOngoing2016-11-18
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Class IIOngoing2016-08-09
Possible injury due to movement of the arm, calibration loss and communication loss.

All facilities operated by Swissray Medical AG

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. “SWISSRAY Medical, AG (FEI 3002143662) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002143662-swissray-medical-ag/

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