Facility

Agfa Gevaert N.V.

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

Key facts

1recalls · 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)	3002809633
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	27 Septestraat Mortsel Antwerpen, BE B 2640
Registration status	Active · expires 2026
Parent company	Agfa Gevaert N.V. (owner-operator 10023132)
Brand names	Drystar DT 2 Mammo; Radiomat LS; Drystar DT 2 B; Ortho CP-GU M; CP-BU M

Activity by year

Recalls (1)

Devices registered here (1)

Film, Radiographic
Product code IWZ (opens in a new tab) · Class I · Radiology · 21 CFR 892.1840

Recalls & enforcement

Class IITerminated2018-12-04
After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intend…

All facilities operated by Agfa Gevaert N.V.

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. “Agfa Gevaert N.V. (FEI 3002809633) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002809633-agfa-gevaert-n-v/

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