VOLISTA ACCESS ARDVCS209007ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03700712401351), received between Jul 7, 2022 and Apr 1, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752692 ↗
• MalfunctionNov 17, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS PEELING OFF THE SUSPENSION 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 23568981 ↗
• MalfunctionOct 29, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THE PAINT WAS PEELING OFF THE DEVICE. 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 23413108 ↗
• MalfunctionFeb 3, 2025Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THAT DURING DISMANTLING OF THE SPRING ARM CORROSION ISSUE WAS FOUND ON VARIOUS PARTS OF THE ARMS. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE CORROSION OCCURED ON SPRING ARM AND ALSO THE PAINT WAS PEELING FROM FORK. 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 21291026 ↗
• MalfunctionAug 27, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074261 ↗
• MalfunctionAug 8, 2024Peeled/Delaminated; Peeled/Delaminated

  ON 22TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 400. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS PEELING FROM THE FORK. 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 19937627 ↗
• MalfunctionApr 26, 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 19190023 ↗
• MalfunctionDec 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON 11TH DECEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THE WATER ENTERED INTO THE LAMP'S POWER SUPPLIES, CAUSING DAMAGE. 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 18318708 ↗
• MalfunctionApr 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 19TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THE COVER WAS LOOSE AND FELL OFF FROM THE DEVICE. 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 16783410 ↗
• MalfunctionJul 12, 2022Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 600. IT WAS STATED THE CORROSION HAS BUILT UP ON THE SAFETY RING AND PIN OF THE SPRING ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14985671 ↗
• MalfunctionJul 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 600. IT WAS STATED THE HEADLIGHT FELL. ONE OF THE ROOM ATTENDANT HAD A MILD SHOULDER CONTUSION. FROM INFORMATION OBTAINED FROM BOTH THE TECHNICAL DEPARTMENT AND THE DINING ROOM STAFF, IT WAS DISCOVERED THAT HEADLIGHT WAS REASSEMBLED BY THE HOSPITAL'S HC GLOBAL SERVICE COMPANY. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF MAY CAUSE SERIOUS INJURY.

  Patient problems: Bruise/Contusion

  MAUDE report 14941468 ↗

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

…and 4 more.