Volista ARDVCS629120A

• EUDAMED Basic UDI-DI 3700712432607S4 registered 11 May 2023 Active
• FDA 510(k) K130513 decided 8 May 2013 Active
• FDA GUDID UDI-DI 03700712436452 listed 20 Jul 2026 Listed

• • Ongoing Z-0758-2024 FDA Class II ·initiated 8 Nov 2023 ·on shared 510(k) K130513

  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 ·on shared 510(k) K130513
  • Terminated Z-1853-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1864-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1858-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1855-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1860-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1862-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1856-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1859-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1854-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1863-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1861-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513
  • Terminated Z-1857-2019 FDA Class II ·initiated 28 May 2019 ·on shared 510(k) K130513

  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 ·on shared 510(k) K130513

  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 ·on shared 510(k) K130513

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 28 May 2019 Recall initiated FDA recalls Z-1856-2019
2. 28 May 2019 Recall initiated FDA recalls Z-1859-2019
3. 28 May 2019 Recall initiated FDA recalls Z-1854-2019
4. 28 May 2019 Recall initiated FDA recalls Z-1863-2019
5. 28 May 2019 Recall initiated FDA recalls Z-1861-2019
6. 28 May 2019 Recall initiated FDA recalls Z-1857-2019
7. 6 May 2022 Recall initiated FDA recalls Z-1308-2022
8. 11 May 2023 Registered EUDAMED 3700712432607S4
9. 8 Nov 2023 Recall initiated FDA recalls Z-0758-2024
10. 20 Jul 2026 Listed FDA GUDID 03700712436452

12 earlier events are in the sections above.

Trade name

VCSII66DF Cv SAX0810 EUDAMED

Volista GUDID

Generic name

Operating room light

Model / reference

ARDVCS629120A, Volista Access II

Primary DI / UDI-DI

03700712436452

Basic UDI-DI

3700712432607S4

Direct marketing DI

03700712436452

510(k) Number

K130513 ↗

FDA product code

FSY

EMDN code

Z12010701 Fixed scialytic lamps

GMDN term

Operating room light

Device class

Class I EUDAMED

Class II GUDID

Regulation number

878.4580

EU registration type

Standard device

EU market of registration

France

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Other devices filed under SCIALYTIC LAMP LIGHTING SYSTEMS.

• TruLight 1000 / ceiling 4058110 by Baxter Medical Systems GmbH + Co. KG
• LED Shadowless Operating Light - by Shandong Lewin Medical Equipment Co., Ltd.
• DIXION 1410 by Dixion Vertrieb medizinischer Geräte GmbH
• Polaris 600 G16720 by Drägerwerk AG & Co. KGaA
• LEDview plus 6558337 by SIRONA Dental Systems GmbH
• SLIM LAMPADA LC010Z17 by Tecno-Gaz S.p.A
• TruLight 1000 / wall 4058120 by Baxter Medical Systems GmbH + Co. KG

• PWDII50SF Vp K3 Xo XHD127 SAX081216

  Class I

  CE/MDR

• Volista ARDVCS209059A Open recall

  Class II

  CE/MDR FDA 510(k) K130513 Active Cleared 8 May 2013 +1authorizations

• Volista ARDVCS209061A Open recall

  Class II

  CE/MDR FDA 510(k) K130513 Active Cleared 8 May 2013 +1authorizations

• Volista ARDVCS209062A Open recall

  Class II

  CE/MDR FDA 510(k) K130513 Active Cleared 8 May 2013 +1authorizations

See all devices from Maquet SAS →