Volista ARDVCS209030ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700712420635), received between Feb 28, 2024 and Aug 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

19 other recalls cover devices cleared under the same FDA submission (K130513); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Detachment of Device or Device Component

  Getinge became aware of an issue with one of surgical lights ¿ Volista Access II. As it was stated, the keypad has detached from the board and fall into sterile field during procedure. There was no injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190649 ↗
• MalfunctionOct 17, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF ITS SURGICAL LIGHTS ¿ THE VOLISTA ACCESS II. AN EMPLOYEE FROM THE DESIGNATED COMPLAINT UNIT NOTICED THE PRESENCE OF PAINT CHIPPING ON THE SUPPORT. NO INJURIES HAVE BEEN REPORTED, HOWEVER WE DECIDED TO REPORT THIS ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY PARTICLES FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE COULD CAUSE CONTAMINATION IN THE EVENT OF RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321091 ↗
• MalfunctionOct 17, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF ITS SURGICAL LIGHTS ¿ THE VOLISTA ACCESS II. AN EMPLOYEE FROM THE DESIGNATED COMPLAINT UNIT NOTICED THE PRESENCE OF PAINT CHIPPING ON THE SUPPORT ARM, SPRING ARM, AND FORK. NO INJURIES HAVE BEEN REPORTED, HOWEVER WE DECIDED TO REPORT THIS ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY PARTICLES FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE COULD CAUSE CONTAMINATION IN THE EVENT OF RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321090 ↗
• MalfunctionMar 17, 2025Crack; Crack

  MANUFACTURER'S REFERENCE NUMBER OT#(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616543 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHT - VOLISTA ACCESS II. AS IT WAS STATED, SPRING ARM COVER FALLS OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394462 ↗
• MalfunctionFeb 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON 16TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS II. IT WAS STATED THE WATER WAS LEAKING FROM THE CEILING, AFTER BREAKAGE OF WATER SYSTEM PIPE AND THE DAMAGE CERTAINLY SPREAD WITHIN THE ELECTRICAL CIRCUITRY AND ON THE ROTATING CONTACTS INSIDE THE SUSPENSION ARMS. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE THE WATER HAS INFILTRATED INSIDE THE DOME. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798127 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130513. One submission often covers many models, so check the product and lot details in each record.

• Z-0758-2024 · Nov 8, 2023 · Open, Classified
  Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP
• Z-1308-2022 · May 6, 2022 · Open, Classified
  VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST
• Z-1862-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
• Z-1858-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
• Z-1853-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
• Z-1860-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
• Z-1852-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
• Z-1863-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
• Z-1854-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
• Z-1856-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
• Z-1855-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
• Z-1861-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
• Z-1864-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
• Z-1857-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
• Z-1859-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM

…and 4 more.