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POWERLED TM ARDPWD209010ARecalls & reported problems

Maquet Sas · PWD30+SF HOR K3 · Class 2

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

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. How this data works · Data updated Oct 13, 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 · FDA record ↗

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.