VOLISTA ACCESS ARDVCS209005ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700712401313), received between Mar 5, 2024 and Feb 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THAT PAINT WAS DAMAGED ON FORK AND SUSPENSION ARM. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING ON SUSPENSION ARM AND FORK AND ALSO INDICATED PAINT CHIPPING AND RUST ON SUSPENSION ARM AND MAIN TUBE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408726 ↗
• MalfunctionFeb 11, 2025Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THAT PAINT WAS DAMAGED ON FORK AND SUSPENSION ARM. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING ON SUSPENSION ARM AND ALSO INDICATED PAINT CHIPPING AND RUST ON SPRING ARM, SUSPENSION ARM AND MAIN TUBE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354596 ↗
• MalfunctionOct 11, 2024Peeled/Delaminated; Peeled/Delaminated

  ON 1ST OCTOBER, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 400/400. IT WAS STATED, THE PAINT WAS PEELING FROM ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426132 ↗
• MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 27TH APRIL 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED AND ALSO CONFIRMED BY PHOTOGRAPHIC EVIDENCE, THE LOWER ELBOW OF SPRING ARM WAS BROKEN. THE FAILURE WAS EVIDENT DURING A DIAGNOSTIC VISIT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211705 ↗
• MalfunctionMar 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON 27TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THE LAMP WAS FLOODED, THE DEVICE WAS NOT IN USE WHEN THE WATER FELT DOWN FROM UPSTAIRS, NO SURGERIES AT THIS TIME, NO PATIENT INVOLVED. THE WATER WAS DROPPING DOWN FROM DEVICE AND WAS FOUND INSIDE THE UNIT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY LIQUID DROPLETS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF RECURRENCE AND CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836521 ↗

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-1859-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
• Z-1853-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
• Z-1864-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
• Z-1858-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
• Z-1862-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
• Z-1856-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
• Z-1861-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
• Z-1857-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
• Z-1852-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
• Z-1854-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
• Z-1863-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
• Z-1860-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
• Z-1855-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

…and 4 more.