VOLISTA ACCESSRecalls & reported problems across all models

We found 6 models of VOLISTA ACCESS by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2022 and Jun 16, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VOLISTA ACCESS problems

VOLISTA ACCESS models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VOLISTA ACCESS ARDVCS209004A

  Light, surgical, ceiling mounted
  13 reports
• VOLISTA ACCESS ARDVCS209007A

  Light, surgical, ceiling mounted
  11 reports
• VOLISTA ACCESS ARDVCS209005A

  Light, surgical, ceiling mounted
  5 reports
• VOLISTA ACCESS ARDVCS209006A

  Light, surgical, ceiling mounted
  4 reports
• VOLISTA ACCESS ARDVCS209001A

  Light, surgical, ceiling mounted
  2 reports
• VOLISTA ACCESS ARDVCS209002A

  Light, surgical, ceiling mounted
  2 reports

Recent VOLISTA ACCESS adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 11, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777090 ↗
• 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 ↗
• MalfunctionSep 16, 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 WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WAS BROKEN. THE ISSUE WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS BROKEN SCREW HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061678 ↗
• 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 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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