STANDOP VOLISTA® ARDSAT209010ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700712405410), received between Oct 23, 2023 and Dec 6, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2023Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON 9TH NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - SATELITE VOLISTA STANDOP. DURING THE PREVENTIVE MAINTENANCE THE PAINT CHIP AND CORROSION ISSUES WERE DETECTED ON THE SATELLITE TUBE. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT CHIPPING AND RUST OCCURRED ON SPRING ARM AND CEILING COVERS. 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 18272368 ↗
• MalfunctionDec 5, 2023Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - SATELITE VOLSITA STANDOP. DURING THE PREVENTIVE MAINTENANCE THE PAINT CHIP AND CORROSION ISSUES WERE DETECTED ON THE SATELLITE TUBE AND FORK. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT CHIPPING AND RUST OCCURRED ON FORK AND SPRING ARM AND CEILING COVERS. 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 18264845 ↗
• MalfunctionNov 15, 2023Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON 9TH NOVEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ VOLISTA STANDOP. AS IT WAS STATED, PAINT WAS CHIPPING AND CORROSION HAS BUILT UP ON THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138445 ↗
• MalfunctionOct 23, 2023Peeled/Delaminated; Peeled/Delaminated

  ON 13TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED AND ALSO CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT PAINT WAS PEELING FROM FORK. 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 17982936 ↗