STANDOP VOLISTA® ARDVST229039ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700712401634), received between Sep 6, 2023 and Sep 24, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component

  It was reported that during a cesarean section, while adjusting the position of the surgical light, the rear cover detached from the spring arm of the Volista Standop surgical light due to significant mechanical contact and fell onto the sterile table during the operation, resulting in contamination of the sterile instruments. After re-preparing the sterile instruments, the surgery continued, and the procedure time was extended. The issue was confirmed based on photographic evidence. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880943 ↗
• MalfunctionMay 4, 2026Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - STANDOP VOLISTA. AS IT WAS STATED THE PAINT WAS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT PAINT PEELING FROM FORK. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25065321 ↗
• MalfunctionSep 11, 2025Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025078 ↗
• MalfunctionSep 11, 2025Peeled/Delaminated; Peeled/Delaminated

  MANUFACTURER'S REFERENCE NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025076 ↗
• MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED THE NURSING STAFF FOUND THAT A SPRING ARM'S SCREW FROM SURGICAL LIGHT HAD FALLEN OFF DURING ROUTINE INSPECTION. THE HOSPITAL HAD INSTALLED THE SCREWS BY ITSELF, AND THE SURGICAL LAMP WAS IN NORMAL USE. THERE WAS NO INJURY. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099874 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711236 ↗
• MalfunctionSep 6, 2023Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE THE LABEL WAS DAMAGED WITH MISSING PARTICLES. 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 OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688418 ↗

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-1855-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
• Z-1858-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
• 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-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-1862-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
• Z-1861-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
• 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-1857-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
• Z-1864-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
• Z-1856-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

…and 4 more.