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Volista 400; Volista 600

by Maquet S.A.S. 510(k)

Active United States

510(k) K130513

Regulatory status

as of 27 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK130513 Date8 May 2013ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

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 via K130513, on the same 510(k)

    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 via K130513, on the same 510(k)

    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 via K130513, on the same 510(k)

    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 marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
FTD
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Maquet S.A.S.