# K130513: Volista 400; Volista 600

- Pathway: 510(k) (Special)
- Applicant: Maquet S.A.S.
- Decided: May 8, 2013 after 70 days
- Product code: FTD (Lamp, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904965 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070442: Powerled Surgical Light System, Maquet S.A. (2007) Summary page 1.
- K113679: Lucea Led Surgical Light System, Maquet S.A.S. (2012) Summary page 1.

## Recalls of this device
- Nov 8, 2023 · Class II · Z-0758-2024: A potential for a light system to fall in the operating room.
- May 6, 2022 · Class II · Z-1308-2022: 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 
- May 28, 2019 · Class II · Z-1860-2019: 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 infe
- May 28, 2019 · Class II · Z-1862-2019: 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 infe
- May 28, 2019 · Class II · Z-1852-2019: 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 infe
- May 28, 2019 · Class II · Z-1861-2019: 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 infe
- May 28, 2019 · Class II · Z-1858-2019: 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 infe
- May 28, 2019 · Class II · Z-1857-2019: 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 infe
- May 28, 2019 · Class II · Z-1853-2019: 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 infe
- May 28, 2019 · Class II · Z-1856-2019: 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 infe
- May 28, 2019 · Class II · Z-1859-2019: 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 infe
- May 28, 2019 · Class II · Z-1854-2019: 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 infe
- May 28, 2019 · Class II · Z-1864-2019: 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 infe
- May 28, 2019 · Class II · Z-1863-2019: 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 infe
- May 28, 2019 · Class II · Z-1855-2019: 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 infe
- Jun 14, 2018 · Class II · Z-2502-2018: 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 res
- Apr 19, 2018 · Class II · Z-1937-2018: Potential keypad failure on VOLISTA StandOP Surgical Lights.
- Feb 7, 2018 · Class II · Z-1349-2018: 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 detachme
- May 29, 2015 · Class II · Z-1990-2015: 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

## Indications for use
MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

Source page: https://510kreport.com/device/K130513
Methodology: https://510kreport.com/methodology