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POWERLED TM ARD568420051ARecalls & reported problems

Maquet Sas · PWD55+DF XS09 K3 · Class 2

All models of POWERLED TM (280)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712402112), received between Jan 2, 2023 and Jun 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, 2023Open, 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

Device problems

  • Detachment of Device or Device Component2
  • Peeled/Delaminated1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE UPPER KNUCKLE COVERS AND DUST COVER WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17070008 ↗
  • MalfunctionJan 2, 2023Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

    ON 29TH DECEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 500. IT WAS STATED THE UPPER DUST COVER WAS MISSING AND THE PAINT WAS CHIPPING FROM FORKS. 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 16082309 ↗

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

Other Light, surgical, ceiling mounted devices

All Light, surgical, ceiling mounted devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page