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Powerled Surgical Light System

by Maquet S.A.

510(k) K070442

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070442 Date16 Mar 2007ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-3224-2026 FDA Class II initiated 7 Aug 2026

    The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

    • Ongoing Z-0763-2024 FDA Class II initiated 8 Nov 2023

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

    • 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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

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