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Vue PACS

by Philips Medical Systems Nederland B.V.

Ref 8986424

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 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/MDD EUDAMED NumberB-00884838100336 Basic UDI-DI 00884838100336UDI-DIDate28 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838100336 UDI-DI Date18 May 2020ListedStatusListed 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

50 recalls · 1 ongoing · FDA

    • Ongoing Z-0497-2025 FDA Class II initiated 10 Oct 2024

    A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

  • 49 recalls, same reason

    • Terminated Z-0246-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0215-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0260-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0230-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0238-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0243-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0236-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0256-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0235-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0254-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0240-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0226-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0249-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0211-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0231-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0255-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0232-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0221-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0212-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0259-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0217-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0223-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0228-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0225-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0224-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0227-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0214-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0241-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0242-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0258-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0257-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0239-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0234-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0248-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0220-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0213-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0245-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0253-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0251-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0233-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0216-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0237-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0252-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0222-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0218-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0229-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0250-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0244-2014 FDA Class II initiated 16 Sep 2013
    • Terminated Z-0219-2014 FDA Class II initiated 16 Sep 2013

    Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Generic Name
Radiological PACS-dedicated management software
Model / Ref / Catalog
8986424, Vue PACS - 12
Primary DI / UDI-DI
00884838100336
Basic UDI-DI
B-00884838100336
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z110603 Picture archiving and communication systems
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
-1192
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
8986424
GUDID
Vue PACS - 12
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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