Maquet Cardiovascular Us Sales, Llc: 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

Agency Publication Date: June 21, 2019

Affected Products

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

Serial Numbers: 21001, 21002

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP

Serial Numbers: 28004 31006 31065 31066 31067 31068 31071 35010 35012 35044 35045

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

Serial Numbers: 31000 31001 31002 31003 31004 31006 31008 31009 31010 31012 31017 31018 31019 31020 31021 31022 31023 31024 31025 31026 35000 35001 35011 35012 35013 35014 35015 35017 35018 35019 35020 35021 35022 35023 35024 35025 35026 35027 35028 35030 35031 35032 35033 38000 38001 38002 38003 38009 38011 38012 38013 38014 38015 38016 38018 38019 38020 38021 38022 38023 38025 38026 38027

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

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

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

Serial Numbers: 28001 31016 31094 35000 35001 35050 35051

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

Serial Numbers: 500000 500001

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

Serial Numbers: 500002 500003 500004 500005 500007 500008

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM

Serial Numbers: 500005 500006 500007 500008 500009 500020 500021 500022 500025 500026 500027 500028

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM

Serial Numbers: 500017 500018 500019 500020 500021 500022 500024 500027 500028 500029 500030

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF

Serial Numbers: 500007 500008 500010 500011 500012

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF

Serial Numbers: 500055 500062

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF

Serial Numbers: 500003 500004 500005 500006 500007 500010 500011 500012 500013

Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF

Serial Numbers: 500040 500041 500042 500043 500044 500045 500046 500049 500050 500069

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82978

Status: Resolved

Manufacturer: Maquet Cardiovascular Us Sales, Llc

Manufactured In: United States

Units Affected: 13 products (2 units; 11 units; 65 units; 46 units; 7 units; 2 units; 6 units; 12 units; 11 units; 5 units; 2 units; 9 units; 10 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.