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Portrait CAU01

by GE Medical Systems Information Technologies, Inc.

Ref 2102549-001

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00840682139250 UDI-DI Date5 Oct 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00241H4 Basic UDI-DI 00840682139250UDI-DIDate2 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

5 recalls · 5 ongoing · FDA

  • 3 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
    • Ongoing Z-3038-2026 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Physiologic monitoring system alarm
Device Name
Portrait Clinical Alarming Unit
Model / Ref / Catalog
2102549-001, CAU01
Primary DI / UDI-DI
00840682139250
Basic UDI-DI
8406821BUG00241H4
Direct Marketing DI
00840682139250
510(k) Number
FDA Product Code
DQA, MWI, DRG, MSX, BZO
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Physiologic monitoring system alarm
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700, 870.2300, 870.2910, 868.5975
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
2102549-001
GUDID
CAU01
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017529
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems Information Technologies, Inc.

See all devices from GE Medical Systems Information Technologies, Inc. →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No