VOLISTA 400 - Volista 400

• • 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 ·on shared 510(k) K130513

  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 ·on shared 510(k) K130513

  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 ·on shared 510(k) K130513

  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.

510(k) Number

K130513 ↗

FDA Product Code

FTD

Models / Variants

Volista 400

Volista 600

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Lucea LED Surgical Light System Open recall

  Class II

  FDA 510(k) K113679 Active Cleared 12 Jan 2012