POWERLED TM ARDPWD259001ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03700712404383), received between Mar 19, 2022 and Sep 10, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Erosion” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K070442); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Nov 8, 2023Class IIOpen, Classified

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

   Z-0763-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE PAINT WAS PEELING. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS PEELING FROM SUSPENSION ARM AND 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 23014516 ↗
• MalfunctionSep 8, 2023Detachment 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 17709903 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839084 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839082 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839078 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON 14TH OF MARCH, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838878 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED. AS IT WAS STATED, THE STOP PIN WAS DAMAGED. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. 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 13838495 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED. AS IT WAS STATED, THE STOP PIN WAS DAMAGED. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. 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 13838494 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON 14TH MARCH, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED. AS IT WAS STATED, THE STOP PIN WAS DAMAGED. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. 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 13838490 ↗
• MalfunctionMar 21, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED. AS IT WAS STATED, THE STOP PIN WAS DAMAGED. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. 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 13838489 ↗
• MalfunctionMar 19, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824637 ↗
• MalfunctionMar 19, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824564 ↗
• MalfunctionMar 19, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824562 ↗
• MalfunctionMar 19, 2022Material Erosion; Material Erosion

  ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE STOP ON LIGHT HEAD ROTATION IS BROKEN. SUCH ISSUE CAN LEAD TO GRINDING DURING MOVEMENT, CREATING RISK OF DETACHMENT OF FILINGS. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824536 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070442. One submission often covers many models, so check the product and lot details in each record.

• Z-3224-2026 · Aug 7, 2026 · Open, Classified
  PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
• Z-1990-2015 · May 29, 2015 · Terminated
  The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling su