FDA-Device2026-09-30Class IIPROCESSING DEFECT
Maquet PowerLED 300 surgical lighting system recalled for fall hazard
What this means
Maquet PowerLED 300 concealed lighting systems may detach at the connection between the spring arm and suspension arm. This could cause the device to fall and potentially injure someone in an operating room or clinical setting.
- Check if your device matches one of the recalled model numbers (ARD568474114A or ARD567501286) and serial numbers listed in the recall notice
- Contact Maquet SAS or your device representative for instructions on inspection, repair, or replacement
- Do not use the device if you suspect the arm connection is loose or damaged
The agency's original wording
Hazard
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
667
Manufactured in
Parc De Limere, Avenue De La Pomme De Pin; Cs 10008 Ardon, Orleans Cedex 2, France
Products
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3224-2026Want us to check the next one for you?
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