POWERLEDRecalls & reported problems across all models

We found 2 models of POWERLED by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2023 and Nov 3, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (3 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

POWERLED 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.

1. Nov 8, 2023Open, Classified

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

   Z-0763-2024 · Root cause: Equipment maintenance · names 2 of these models · Recall details · FDA record ↗

Most reported POWERLED problems

POWERLED models

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

• POWERLED ARD267800200A

  Light, surgical, ceiling mounted
  1 recall3 reports
• POWERLED ARDPWD219010A

  Light, surgical, ceiling mounted
  1 recall0 reports

Recent POWERLED adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component

  ON 5TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED AND ALSO CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT SPRING ARM COVER SCREWS AND CEILING MOUNTING HARDWARE WERE RUSTED AND THAT COVER ON CEILING MOUNT WAS MISSING. DEVICE WAS INSTALLED ON THE SHIP WHICH IS STILL UNDER CONSTRUCTION. NO CLEANING OR DISINFECTION PROCESSES HAVE BEEN PERFORMED. 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 SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064524 ↗
• MalfunctionNov 3, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component

  ON 5TH OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT RUST OCCURRED ON CEILING MOUNTING BOLTS/STUDS AND NUTS, AND ALSO THERE WAS LACK OF CEILING COVER WHICH COULD LEAD TO FALLING CONTAMINATIONS FROM THE HOLE ABOVE CEILING TO STERILE FIELD. DEVICE WAS INSTALLED BY ONSITE CUSTOMER CONTRACTORS ON THE SHIP, WHICH IS STILL UNDER CONSTRUCTION, THE DEVICE IS NOT IN SERVICE BY CUSTOMER YET. NO CLEANING OR DISINFECTION PROCESSES HAVE BEEN PERFORMED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLES OR OTHER PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064428 ↗
• MalfunctionOct 20, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component

  ON 5TH OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT RUST OCCURRED ON CEILING MOUNTING BOLTS/STUDS AND NUTS, AND ALSO THERE WAS LACK OF CEILING COVER WHICH COULD LEAD TO FALLING CONTAMINATIONS FROM THE HOLE ABOVE CEILING TO STERILE FIELD. DEVICE WAS INSTALLED BY ONSITE CUSTOMER CONTRACTORS ON THE SHIP, WHICH IS STILL UNDER CONSTRUCTION, THE DEVICE IS NOT IN SERVICE BY CUSTOMER YET. NO CLEANING OR DISINFECTION PROCESSES HAVE BEEN PERFORMED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLES OR OTHER PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975631 ↗

Other Maquet Sas products

• Maquet PowerLED II992 models · 138 reports · 1 recall
• POWERLED TM280 models · 79 reports · 2 recalls
• STANDOP VOLISTA23 models · 56 reports · 1 recall
• 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