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Terminated

Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

FDA Recall Z-1730-2014 · Posted 2014-06-06

Recalling FirmMaquet Medical Systems USA
Recall StatusTerminated
Product CodeFSY
Date Initiated2014-04-16
Date Terminated2016-04-06
Product QuantityUnited States 1169 units

Reason for Recall

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.

Firm 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 or require additional information, the notice instructs them to contact their local MAQUET representative, or MAQUET Customer Service at 1-888-627-8383 (option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Root Cause

Other

Distribution Pattern

US Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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