medical Class II Updated 2019-07-03

Maquet Cardiovascular Us Sales, Llc recalls Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD56

Recalled Product

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Serial Numbers: 25004 25005 25006 25007 28003 28004 31000 31001 31002 31003 31004 31005 31006 31008 31009 31011 31012 31013 31014 31015 31016 31017 31019 31020 31030 31039 31040 31041 31042 31043 31044 31045 31046 31047 31048 31050 31051 31052 31053 31054 31055 31056 38025 38026 38027 38028

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