Facility

ARCOMA AB

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)	3002675731
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	ANNAVAGEN 1 VAXJO Kronoberg, SE 35246
Registration status	Active · expires 2026
Parent company	ARCOMA AB (owner-operator 9035990)
Brand names	ARCOCEIL

Activity by year

Recalls (1)

Devices registered here (1)

Tube Mount, X-Ray, Diagnostic
Product code IYB (opens in a new tab) · Class I · Radiology · 21 CFR 892.1770

Recalls & enforcement

Class IIOngoing2021-05-05
There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

All facilities operated by ARCOMA AB

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. “ARCOMA AB (FEI 3002675731) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002675731-arcoma-ab/

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