Facility

PALODEX GROUP OY

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

Key facts

2recalls · worst Class II

1inspections · worst NAI

—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)	3005383085
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	NAHKELANTIE 160 Tuusula Uusimaa, FI 04300
Registration status	Active · expires 2026
Parent company	PaloDEx Group Oy (owner-operator 9079085)
Brand names	DTX Studio Assist

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (2)

Analyzer, Medical Image
Product code MYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.2070
Automated Radiological Image Processing Software
Product code QIH (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IIOngoing2021-10-28
It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).
Class IITerminated2020-01-07
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

FDA inspections (1)

NAI2019-01-31
No Action Indicated · Postmarket Assurance: Devices; Radiation Control and Health Safety Act

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by PaloDEx Group Oy

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. “PALODEX GROUP OY (FEI 3005383085) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005383085-palodex-group-oy/

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