Facility

HERMES MEDICAL SOLUTIONS, 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)	3002831423
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Strandbergsgatan 16 STOCKHOLM, SE 11251
Registration status	Active · expires 2026
Parent company	HERMES MEDICAL SOLUTIONS AB (owner-operator 9047204)
Brand names	OLINDA; OLINDA/EXM; Hermia

Activity by year

Recalls (1)

Devices registered here (1)

Camera, Scintillation (Gamma)
Product code IYX (opens in a new tab) · Class I · Radiology · 21 CFR 892.1100

Recalls & enforcement

Class IIOngoing2024-10-31
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.

All facilities operated by HERMES MEDICAL SOLUTIONS 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. “HERMES MEDICAL SOLUTIONS, AB (FEI 3002831423) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002831423-hermes-medical-solutions-ab/

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