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Portrait HSWXB

by GE Healthcare Finland Oy Finland EUDAMEDGUDID

Ref 5700672-12Model Version 1.1 Product code BZQEMDN Z1203020292

Regulatory status

as of 25 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00198953030981 UDI-DIDate10 Dec 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number8406821BUG00457HV Basic UDI-DIDate19 Dec 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

4 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3036-2026 FDA Class II initiated 20 Jul 2026
    • Ongoing Z-3037-2026 FDA Class II initiated 20 Jul 2026

    Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

    • Ongoing Z-2878-2026 FDA Class II initiated 10 Jul 2026

    Portrait Core Services Software version V1.2.0 Security Vulnerability

    • Ongoing Z-0918-2025 FDA Class II initiated 6 Dec 2024

    There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
Physiologic monitor-installed software
Model / Ref / Catalog
Version 1.1, 5700672-12, V1.2
Primary DI / UDI-DI
00198953030981
Basic UDI-DI
8406821BUG00457HV
510(k) Number
FDA Product Code
BZQ, DQA, DRG, MSX, MWI
EMDN Code
Z1203020292 Multi-parameter monitors - medical device software
GMDN Term
Physiologic monitor-installed software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.2375, 870.2700, 870.2910, 870.2300
Special Device Type
Software
Market of Registration
Finland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Version 1.1
5700672-12
GUDID
V1.2
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED ebb23f74-04e0-4415-b56d-908bed363b52 61 fields · synced 23 Oct 2026
  • FDA UDI b8d35446-3546-4e5c-b10e-df10926bc4c7 35 fields · synced 23 Oct 2026