Recall Z-3224-2026 ยท FSY Light, Surgical, Ceiling Mounted
Maquet SAS
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
| Date | Sep 18, 2026 (initiated Aug 7, 2026) |
| Status | Open, Classified |
| Reason | The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. |
| Root cause | Process control |
| 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 |
| Quantity | 667 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070442 | POWERLED SURGICAL LIGHT SYSTEM Maquet S.A., Mar 16, 2007 |