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Volista ARDVCS639167A

by Maquet, Inc.

Ref ARDVCS639167AModel Volista Access II

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03700712437879 UDI-DI Date20 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3700712432607S4 Basic UDI-DI 03700712437879UDI-DIDate11 May 2023RegisteredStatusActive

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

19 recalls · 2 ongoing · FDA

    • Ongoing Z-0758-2024 FDA Class II initiated 8 Nov 2023 on shared 510(k) K130513

    A potential for a light system to fall in the operating room.

    • Ongoing Z-1308-2022 FDA Class II initiated 6 May 2022

    Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

  • 13 recalls, same reason

    • Terminated Z-1852-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1853-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1864-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1858-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1855-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1860-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1862-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1856-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1859-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1854-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1863-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1861-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513
    • Terminated Z-1857-2019 FDA Class II initiated 28 May 2019 on shared 510(k) K130513

    Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection

    • Terminated Z-2502-2018 FDA Class II initiated 14 Jun 2018 on shared 510(k) K130513

    Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.

    • Terminated Z-1937-2018 FDA Class II initiated 19 Apr 2018 on shared 510(k) K130513

    Potential keypad failure on VOLISTA StandOP Surgical Lights.

    • Terminated Z-1349-2018 FDA Class II initiated 7 Feb 2018

    The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.

    • Terminated Z-1990-2015 FDA Class II initiated 29 May 2015

    Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
VCSII44DF Tk Cv XHS021 SAX081012 EUDAMED
Volista GUDID
Generic Name
Operating room light
Model / Reference
ARDVCS639167A, Volista Access II
Primary DI / UDI-DI
03700712437879
Basic UDI-DI
3700712432607S4
Direct Marketing DI
03700712437879
510(k) Number
FDA Product Code
FSY
EMDN Code
Z12010701 Fixed scialytic lamps
GMDN Term
Operating room light
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4580
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K130513)

Show all (12)

Other devices from Maquet, Inc.

See all devices from Maquet, Inc. →

Properties

  • Serial Number
  • Manufacturing Date

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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No