VolistaRecalls & reported problems across all models

We found 14 models of Volista by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2023 and Sep 24, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 problems

Volista models

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

• Volista ARDVCS209030A

  Light, surgical, ceiling mounted
  6 reports
• Volista ARDVCS209018A

  Light, surgical, ceiling mounted
  4 reports
• Volista ARDVCS209031A

  Light, surgical, ceiling mounted
  4 reports
• Volista ARDVST229090A

  Light, Surgical, Ceiling Mounted
  1 report
• Volista ARDVCS209015A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVCS209016A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVCS209023A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVCS209027A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVCS209028A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVCS209029A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVCS209032A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVCS209042A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVST639011A

  Light, surgical, ceiling mounted
  1 report
• Volista ARDVST629114A

  Light, surgical, ceiling mounted
  1 report

Recent Volista adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component

  Getinge became aware of an issue with one of surgical lights - VOLISTA ACCESS II. It was stated that the support of the keypad had come loose. The keypad fell onto the surgical field fabric during an intervention. No harm to the patient or operator was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880957 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  Getinge became aware of an issue with one of surgical lights - VOLISTA STANDOP. It was stated that the light was not working prior to use. During the inspection, it was noted that the snap ring securing the spring arm bushing had come loose. No harm to the patient or operator was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472420 ↗
• MalfunctionAug 10, 2026Detachment of Device or Device Component

  Getinge became aware of an issue with one of surgical lights ¿ Volista Access II. As it was stated, the keypad has detached from the board and fall into sterile field during procedure. There was no injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190649 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE SURGICAL LIGHTS - VOLISTA ACCESS II. AS REPORTED, THE SPRING ARM COVER FELL ONTO THE OPERATING TABLE AND CAME INTO CONTACT WITH STERILE EQUIPMENT DURING SURGERY. THERE WAS NO INJURY REPORTED AND NO DELAY TO THE PROCEDURE DUE TO THE INCIDENT. HOWEVER, WE DECIDED TO REPORT THE ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY PARTS FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE MAY CAUSE INJURY OR CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388175 ↗
• MalfunctionDec 11, 2025Detachment 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 23777339 ↗
• MalfunctionNov 27, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS II. IT WAS STATED THAT THE RING OF CELLING COVER HAS BEEN DAMAGED. 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 INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664351 ↗
• MalfunctionNov 27, 2025Material Integrity Problem; Material Integrity Problem

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THE RING OF CELLING COVER HAS BEEN DAMAGED. 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 INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664292 ↗
• MalfunctionOct 17, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF ITS SURGICAL LIGHTS ¿ THE VOLISTA ACCESS II. AN EMPLOYEE FROM THE DESIGNATED COMPLAINT UNIT NOTICED THE PRESENCE OF PAINT CHIPPING ON THE SUPPORT. NO INJURIES HAVE BEEN REPORTED, HOWEVER WE DECIDED TO REPORT THIS ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY PARTICLES FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE COULD CAUSE CONTAMINATION IN THE EVENT OF RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321091 ↗
• MalfunctionOct 17, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF ITS SURGICAL LIGHTS ¿ THE VOLISTA ACCESS II. AN EMPLOYEE FROM THE DESIGNATED COMPLAINT UNIT NOTICED THE PRESENCE OF PAINT CHIPPING ON THE SUPPORT ARM, SPRING ARM, AND FORK. NO INJURIES HAVE BEEN REPORTED, HOWEVER WE DECIDED TO REPORT THIS ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY PARTICLES FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE COULD CAUSE CONTAMINATION IN THE EVENT OF RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321090 ↗
• MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHT - VOLISTA STANDOP. AS IT WAS STATED, SPRING ARM COVER FALLS OFF NEAR THE PATIENT'S ABDOMINAL INCISION DURING SURGERY. THERE WAS NO INJURY REPORTED, HOWEVER, 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 22960844 ↗
• MalfunctionAug 7, 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. CUSTOMER REPORTED THAT A SCREW IN THE SPOTLIGHT'S STRUCTURE FELL OUT DURING A SURGICAL PROCEDURE, AND THAT THE SCREW FELL ONTO THE PATIENT. THE PATIENT WAS NOT HARMED BY THE INCIDENT. THE SCREW WAS RETIGHTENED TO ENSURE ITS FIXATION. THE SCREW IS PLACED IN THE SPRING ARM AND HOLDS THE SAFETY RING AND THE SPOTLIGHT DOME. 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 22736481 ↗
• MalfunctionMar 24, 2025Unintended Movement; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676722 ↗
• MalfunctionMar 17, 2025Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616543 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHT - VOLISTA ACCESS II. AS IT WAS STATED, SPRING ARM COVER FALLS OFF. THERE WAS NO INJURY REPORTED, HOWEVER, 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 21394462 ↗
• MalfunctionDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892351 ↗

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