PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
FDA Recall Z-3224-2026 · Posted 2026-09-18
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Recalling FirmMaquet SAS
Recall StatusOpen, Classified
Product CodeFSY
Date Initiated2026-08-07
Product Quantity667
Reason for Recall
The potential for the device to detach
at the junction between the spring arm and suspension arm and fall causing potential injury.
Firm Action
On August 7, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers.
Actions to be taken:
1. Identify any affected light(s) in your facility. Do not use affected light(s) until Getinge has completed the inspection and any required repairs. You may continue to use the room where the light is located. The light enclosure must remain closed; use an alternative light source as needed.
2. Forward this notification to anyone in your organization, or any organization Where the affected devices were transferred, who needs to be aware.
3. Complete and return the enclosed response form to [email protected].
Root Cause
Process control
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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