STANDOP VOLISTARecalls & reported problems across all models
Maquet Sas · 23 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one STANDOP VOLISTA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 23 models of STANDOP VOLISTA by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Aug 12, 2022 and Sep 24, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (28 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
STANDOP VOLISTA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 6, 2022Class IIOpen, Classified
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.
Z-1308-2022 · Root cause: Process change control · names 8 of these models · Recall details · FDA record ↗
Most reported STANDOP VOLISTA problems
Device problems
- Peeled/Delaminated28
- Detachment of Device or Device Component19
- Corroded14
- Fluid/Blood Leak3
- Crack2
- Fracture2
- Break1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions56
STANDOP VOLISTA models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STANDOP VOLISTA® ARDVST229003ALight, surgical, ceiling mounted1 recall2 reports
- STANDOP VOLISTA® ARDVST229002ALight, surgical, ceiling mounted1 recall2 reports
- STANDOP VOLISTA® ARDVST229037ALamp, surgical1 recall1 report
- STANDOP VOLISTA® ARDVST229035ALamp, surgical1 recall0 reports
- STANDOP VOLISTA® ARDVST229001ALight, surgical, ceiling mounted1 recall0 reports
- STANDOP VOLISTA® ARDVST229034ALamp, surgical1 recall0 reports
- STANDOP VOLISTA® ARDVST229000ALight, surgical, ceiling mounted1 recall0 reports
- STANDOP VOLISTA® ARDVST229036ALight, surgical, ceiling mounted1 recall0 reports
- STANDOP VOLISTA® ARDVST229019ALight, surgical, ceiling mounted8 reports
- STANDOP VOLISTA® ARD267900100ALamp, Surgical8 reports
- STANDOP VOLISTA® ARDVST229039ALight, surgical, ceiling mounted7 reports
- STANDOP VOLISTA® ARDVST229009ALight, surgical, ceiling mounted5 reports
- STANDOP VOLISTA® ARDVST229008ALight, surgical, ceiling mounted5 reports
- STANDOP VOLISTA® ARDVST229029ALamp, surgical4 reports
- STANDOP VOLISTA® ARDSAT209010ALamp, surgical4 reports
- STANDOP VOLISTA® ARDVST229038ALamp, surgical2 reports
- STANDOP VOLISTA® ARDVST229017ALamp, surgical2 reports
- STANDOP VOLISTA® ARDVST229011ALight, surgical, ceiling mounted1 report
- STANDOP VOLISTA® ARDVST229033ALamp, surgical1 report
- STANDOP VOLISTA® ARDVST229013ALight, surgical, ceiling mounted1 report
- STANDOP VOLISTA® ARDVST229028ALamp, surgical1 report
- STANDOP VOLISTA® ARDSAT209018ALight, surgical, ceiling mounted1 report
- STANDOP VOLISTA® ARD2STP00070ALamp, Surgical1 report
Recent STANDOP 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
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 ↗MalfunctionJun 24, 2026Peeled/Delaminated
Manufacturer's reference number (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25606175 ↗MalfunctionJun 12, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED THAT PAINT WAS DELAMINATED 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 25484312 ↗MalfunctionMay 15, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THERE WAS A CRACK ON FORK THAT COULD LEAD TO THE FALL OF PAINT PARTICLES. 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 25180327 ↗MalfunctionMay 6, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT PAINT WAS PEELING OFF ON SPRING 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 25092831 ↗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 ↗MalfunctionApr 7, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS: VOLISTA STANDOP. IT WAS STATED THAT THERE WAS A SIGNIFICANT PAINT LOSS ON 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 24799128 ↗MalfunctionApr 7, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED THAT THERE WAS A SIGNIFICANT PAINT LOSS ON 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 24799089 ↗MalfunctionApr 7, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED THAT THERE WAS A SIGNIFICANT PAINT LOSS ON 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 24799086 ↗MalfunctionMar 18, 2026Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS: VOLISTA STANDOP. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WAS LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS 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 24632242 ↗MalfunctionMar 18, 2026Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WAS LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS 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 24626399 ↗MalfunctionNov 18, 2025Peeled/Delaminated; Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED THE PAINT WAS PEELING OFF 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 23581763 ↗MalfunctionOct 22, 2025Scratched Material; Scratched Material
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356030 ↗MalfunctionSep 17, 2025Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED THE RUST OCCURRED ON THE CEILING COVER AND IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. 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 23070774 ↗MalfunctionSep 11, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER OT# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025078 ↗
Other Maquet Sas products
- Maquet PowerLED II992 models · 138 reports · 1 recall
- POWERLED TM280 models · 79 reports · 2 recalls
- Maquet Rolite17 models · 1 reports · 2 recalls
- LUCEA LED33 models · 51 reports · 1 recall
- ROLITE VOLISTA STANDOP8 models · 0 reports · 2 recalls
- Maquet Equipment45 models · 8 reports · 1 recall
- Maquet Orchide5 models · 4 reports · 1 recall
- POWERLED2 models · 3 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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