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AW Server (version: 3.2)

by GE Medical Systems SCS

Ref 5719780

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 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
European UnionCE/MDR EUDAMED Number8406821BUG00119H6 Basic UDI-DI 00840682102384UDI-DIDate20 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682102384 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution

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 · 2 ongoing · FDA

    • Ongoing Z-2553-2026 FDA Class II initiated 8 May 2026

    GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.

    • Ongoing Z-0068-2026 FDA Class II initiated 5 Sep 2025

    Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

    • Terminated Z-0270-2014 FDA Class II initiated 19 Sep 2013

    GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc

    • Terminated Z-1137-2013 FDA Class II initiated 28 Jun 2012

    GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe

    • Terminated Z-0486-2012 FDA Unclassified (pre-2012) initiated 17 Nov 2011

    2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also, if a second patient exam is selected while the application is starting, the second patient's data will be displayed with the first patient's name display on the applications tab.

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

Trade Name
AW Server (version: 3.2) EUDAMED
AW Server GUDID
Generic Name
Radiological PACS-dedicated management software
Model / Reference
5719780 EUDAMED
3.2 GUDID
Primary DI / UDI-DI
00840682102384
Basic UDI-DI
8406821BUG00119H6
Direct Marketing DI
00840682102384
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5719780
GUDID
3.2
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000000687

Other devices from GE Medical Systems SCS

See all devices from GE Medical Systems SCS →

Properties

  • 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