Facility

Demant Technology Centre Sp. z o.o.

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

Key facts

5recalls · 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)	3014404697
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Q22, Al. Jana Pawla II 22, 9th Floor Warsaw Mazowieckie, PL 00133
Registration status	Active · expires 2026
Parent company	VISION RT LIMITED (owner-operator 9063759)
Brand names	AlignRT system; OSMS; AlignRT; AlignRT Plus; GateRT system; GateCT system; AlignRT SRS module

Activity by year

Recalls (5)

Devices registered here (1)

Accelerator, Linear, Medical
Product code IYE (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

Class IIOngoing2025-08-27
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via c…
Class IITerminated2018-08-24
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
Class IITerminated2016-06-30
Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM …
Class IITerminated2014-11-11
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
Class IITerminated2014-10-15
Potential failure of AlignRT to assert interlock.

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. “Demant Technology Centre Sp. z o.o. (FEI 3014404697) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014404697-demant-technology-centre-sp-z-o-o/

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