Recall Z-1730-2014— Maquet Medical Systems USA

Name: FDA recall Z-1730-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-16

Class II · Terminated

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2014-04-16, terminated 2016-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.. 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..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Terminated: 2016-04-06
Firm location: Wayne, NJ, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.