Maquet PowerLED II ARDPWT259215ARecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03700712413897), received between Aug 9, 2023 and Feb 4, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 reports).

1 FDA recall record name this device's 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, 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 18, 2026.

Recalls naming this device

1. Nov 8, 2023Class IIOpen, Classified

   A potential for a light system to fall in the operating room.

   Z-0757-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301860 ↗
• MalfunctionFeb 3, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS 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 21290826 ↗
• MalfunctionJan 30, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE PAINT WAS CHIPPING FROM FORK AND HEADLIGHT. THE CLEANING PROCESS HAS NOT BEEN FOLLOWED. 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 21273339 ↗
• MalfunctionJan 30, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE PAINT WAS CHIPPING 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 21273221 ↗
• MalfunctionJan 30, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - MAQUET POWERLED II. IT WAS STATED THE PAINT WAS CHIPPING BETWEEN FORK AND HEADLIGHT. 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 21271951 ↗
• MalfunctionJan 30, 2025Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271732 ↗
• MalfunctionJan 29, 2025Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262207 ↗
• MalfunctionOct 24, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521901 ↗
• MalfunctionOct 22, 2024Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THE PAINT WAS CHIPPING ON THE 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 20503504 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682765 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON (B)(6), 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682663 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682446 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682343 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682342 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682341 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682340 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON(B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682339 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682338 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682333 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682332 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682170 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682169 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682167 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682165 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON 7TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682164 ↗