VOLISTA ACCESS ARDVCS209004ARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03700712401320), received between Mar 23, 2023 and Jun 16, 2026 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED AND CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT PAINT WAS PEELING OFF ON SPRING ARM, SUSPENSION ARM AND MAIN TUBE. 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 25517655 ↗
• MalfunctionFeb 10, 2026Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT PAINT WAS CHIPPING ON 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 24302112 ↗
• MalfunctionMay 14, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED PAINT PEELING OCCURRED ON THE SUSPENSION ARM AND THE MAIN TUBE. ISSUES WERE CONFIRMED BY PHOTOGRAPHIC EVIDENCE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016784 ↗
• 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 MAIN TUBE AND FORK AND ALSO INDICATED RUST ON 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 21410977 ↗
• MalfunctionFeb 18, 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 21396785 ↗
• MalfunctionJan 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT IS OBSERVED THAT THE METAL STRUCTURE (CLINICAL INFRASTRUCTURE) WHERE THE ANCHOR IS AND WHERE THE SUSPENSION TUBE AND THE ARMS AND SATELLITES OF THE LAMP ARE INSTALLED OSCILLATE WITH CLOCKWISE AND COUNTERCLOCKWISE MOVEMENTS AND THE VERTICAL LEVEL OF THE SUSPENSION TUBE IS NOT CONSTANT DURING THE TURNS, GIVING THE SENSATION OF INSTABILITY OF THE LAMP AND WITHOUT VERTICAL LEVEL. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE CONNECTION BETWEEN MAIN TUBE AND SUSPENSION ARM COULD LEAD TO FALL OF WHOLE CONFIGURATION AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217559 ↗
• MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101724 ↗
• MalfunctionAug 22, 2024Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035185 ↗
• MalfunctionJan 30, 2024Moisture Damage; Moisture Damage

  ON (B)(6) 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 400/400. AS IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE, THE LIGHT DID NOT TURN ON DUE TO RAINWATER THAT INFILTERED THROUGH THE CEILING AND REACHED THE MAIN TUBE AS WELL AS CEILING POWER SUPPLY LEADING TO DAMAGE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK IN CASE OF REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605220 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON 24TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THE RAINWATER FILTERED THROUGH THE CEILING, REACHED THE MAIN TUBE AND ALSO WETTING THE CEILING POWER SUPPLIES, DAMAGING THEM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY LIQUID FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION AND CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604717 ↗
• MalfunctionJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 29TH DECEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS. IT WAS STATED THE LABEL WAS MISSING. 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 18434578 ↗
• MalfunctionNov 17, 2023Peeled/Delaminated; Peeled/Delaminated

  ON 10TH NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 400/400. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM THE SUSPENSION ARM, AND THE RUST WAS VISIBLE IN THE PLACE WHERE THE PAINT WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT OR RUST PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON 23TH NOVEMBER 2023 INDICATED THERE WERE NO PAINT CHIPS AND RUST ON THE DEVICE, THE DEVICE WAS DIRTY. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WERE NO PAINT CHIPS AND RUST, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18157492 ↗
• MalfunctionMar 23, 2023Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596332 ↗

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-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-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-1857-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
• Z-1860-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
• Z-1854-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
• Z-1864-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
• Z-1852-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
• Z-1853-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
• Z-1859-2019 · May 28, 2019 · Terminated
  Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
• 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

…and 4 more.