Facility

SONESTA MEDICAL AB

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

Key facts

2recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010496070
Establishment type	Export Device to the United States But Perform No Other Operation on Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	Industrivagen 7 Stockholm, SE 11446
Registration status	Active · expires 2026
Parent company	Sonesta Medical AB (owner-operator 10047317)

Activity by year

Recalls (2)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Table, Radiographic, Tilting
Product code IXR (opens in a new tab) · Class II · Radiology · 21 CFR 892.1980

Recalls & enforcement

Class IIOngoing2025-08-22
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Class IITerminated2017-03-08
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

FDA inspections (2)

OAI2023-06-07
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-06-14
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

FDA warning letters (1)

Warning Letter2023-12-04
Warning Letter (opens in a new tab) · Solna

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Sonesta Medical 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. “SONESTA MEDICAL AB (FEI 3010496070) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010496070-sonesta-medical-ab/

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