Recall Z-1730-2014 ยท FSY Light, Surgical, Ceiling Mounted
Maquet Medical Systems USA
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
| Date | Jun 6, 2014 (initiated Apr 16, 2014) |
| Status | Terminated |
| Reason | Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach. |
| Root cause | Other |
| Action | Maquet issued "Urgent-Medical Device Field Correction" notices, dated April 16, 2014 to affected customers via Federal Express. The notice identified the product, related issue and the action needed to be taken by the customer. The corrective action will include inspection of the fixation tabs of the Ambient Light Module adn replacement of the Ambient Light Module if tabs are found to be defective. The correction will be performed by an authorized MAQUET Service Technician. MAQUET Service Team representatives will schedule on-site service with customers. If customers have any questions o |
| Quantity | United States 1169 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.