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Na ARD567355901

by Maquet, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700712404918 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

19 recalls · 2 ongoing · FDA

    • Ongoing Z-0758-2024 FDA Class II initiated 8 Nov 2023

    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
    • Terminated Z-1853-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1864-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1858-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1855-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1860-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1862-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1856-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1859-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1854-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1863-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1861-2019 FDA Class II initiated 28 May 2019
    • Terminated Z-1857-2019 FDA Class II initiated 28 May 2019

    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

    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

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Operating room light
Model / Reference
ARD567355901
Primary DI / UDI-DI
03700712404918
510(k) Number
FDA Product Code
FTD, FSY
GMDN Term
Operating room light
Device Class
Class II
Regulation Number
878.4580
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Operating room light

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 (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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