DeviceClearance

Recall Z-1990-2015— Maquet Cardiovascular Us Sales, Llc

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2015-05-29, terminated 2017-04-07. It names 3 FDA 510(k) clearances: K130513, K070442, K040735. Product: The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.. Reason: Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table..

Recalling firm
Maquet Cardiovascular Us Sales, Llc
Classification
Class II
Status
Terminated
Initiated
2015-05-29
Terminated
2017-04-07
Firm location
Wayne, NJ, United States

510(k) clearances named in this recall

3 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.

Reason for recall

Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.

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