Recall Z-1857-2019— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-1857-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-28

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2019-05-28, terminated 2023-07-10. It names one FDA 510(k) clearance: K130513. Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM. Reason: Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection.

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Terminated: 2023-07-10
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K130513 — VOLISTA 400; VOLISTA 600Maquet S.A.S.·cleared 2013-05-08

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

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM

Reason for recall

Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection

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