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U.S. Department of Health and Human Services

Class 2 Device Recall VOLISTA StandOP Surgical Light

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  Class 2 Device Recall VOLISTA StandOP Surgical Light see related information
Date Initiated by Firm May 06, 2022
Date Posted June 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-1308-2022
Recall Event ID 90305
510(K)Number K130513  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP
ARD568811911 VLT600SF AIM STP
ARD568811961 VLT600DF AIM STP
ARDVST229000A VST60SF AIM
ARDVST229001A VST60DF AIM
ARDVST229002A VST66SF AIM
ARDVST229003A VST66DF AIM
ARDVST229034A VST60SF
ARDVST229036A VST66SF
ARDVST229037A VST66DF
Code Information Product Code UDI Product Description ARD568811901 N/A VLT600SF AIM STP ARD568811911 N/A VLT600SF AIM STP ARD568811951 N/A VLT600DF AIM STP ARD568811961 N/A VLT600DF AIM STP ARD568812951 N/A VLT400DF AIM STP ARD568821911 N/A VLT600SF AIM STP QL ARD568821961 N/A VLT600DF AIM STP QL ARD568831961 N/A VLT600DF AIM STP ARDROL309018A 3700712400873 VST60 AIM ROL ARDROL309022A 3700712400866 VST40 TK AIM ROL B ARDROL309023A 3700712400903 VST60 TK AIM ROL B ARDVST229000A 3700712401603 VST60SF AIM ARDVST229001A 3700712401566 VST60DF AIM ARDVST229002A 3700712401764 VST66SF AIM ARDVST229003A 3700712401726 VST66DF AIM ARDVST229034A 3700712401597 VST60SF ARDVST229035A 3700712401559 VST60DF ARDVST229036A 3700712401757 VST66SF ARDVST229037A 3700712401719 VST66DF Serial Numbers: AR500002 AR500005 500000 500005 568811961AR031047 568811961AR031052 00002 00005 00006 00007 500005 510001 510002 510003 510004 510005 500029 500030 38009 38026 00125 00126 AR038016 AR038013 00113 500046 500069 AR038019 AR038018 AR038020 AR038021 AR038022 AR038023 AR038025 AR038024 500007 500008 568811911AR035028 568811911AR035025 500000 500001 500003 500004 AR038015 AR038012 AR035028 AR035025 00003 00114 500001 500004 500006 500007 510018 510019 510026 510028 568811961AR031053 AR031053 00001 500004 500027 510011 510012 510013 510014 510015 510017 510020 510021 510022 510023 510024 510062 510063 510064 510057 510058 510059 500026 AR031048 AR031054 31030 AR021001 AR021002 00004 568811911AR035024 AR035024 35024 00110 AR035015 AR035014 AR035013 DEL_AR035012 568811911AR035015 568811911AR035014 568811911AR035013 568811911AR035012 AR035012 35013 35014 35015 00001 00002 510017 500028 500033 568811911AR035027 568811911AR035017 AR035017 AR035027 00108 00109 AR031003 AR031022 AR031026 AR031012 AR031002 AR031001 AR031006 AR031024 AR031025 AR031019 AR031020 AR031009 AR031010 AR03001 AR031000 AR031008 31003 AR031000 510027 AR031051 AR031050 AR031047 AR031052 31050 31051 AR031009 38025 38026 38027 38028 AR031046 AR031044 AR031055 AR031056 AR031043 AR031039 AR031042 AR031040 AR031045 AR031041 568811961AR031046 568811961AR031044 568811961AR031055 568811961AR031056 500002 AR031005 AR031011 25004 31009 31017 31019 31039 31040 31041 31042 31043 31044 31045 31046 31055 31056 31005 568811961AR031043 568811961AR031039 568811961AR031042 568811961AR031040 568811961AR031045 568811961AR031041 500000 00002 00003 00108 500021 500022 00004 00006 00007 00109 25007 500002 500003 500019 500024 500032 500034 500055 500062 500049 500050 500027 500028 510002 510019 510020 510021 500003 500004 500006 AR031012 AR031020 AR031013 AR031014 AR038014 AR038011 00115 AR031015 AR031016 AR031008 AR031006 568811961AR031008 568811961AR031006 31006 31008 31015 31016 00001 00005 500017 500018 AR031021 AR031023 38018 38019 38020 38021 38022 38023 38024 38025 00119 00118 00117 00116 AR031002 31004 00101 AR035011 35011 38027 AR035022 AR035019 AR031017 AR035001 AR035000 AR031018 AR031004 AR035030 AR035033 AR035031 AR035032 AR035021 AR035023 AR035020 AR035026 AR035018 QSUS_0001 QSUS_0002 QSUS_0003 QSUS_0004 QSUS_0005 QSUS_0006 QSUS_0007 QSUS_0008 QSUS_0009 QSUS_0014 QSUS_0010 QSUS_0011 AR031001 AR031003 31001 31003 28003 28004 25005 25006 00008 500010 500012 500011 500000 500001 AR038000 AR038002 00100 500022 500026 510004 510005 510006 510007 510008 510009 510010 510011 510012 500020 500005 500017 500019 500020 500011 AR038001 AR038003 00101 500020 500021 500025 500007 500008 500040 500041 500042 500043 500044 500045 510016 500004 500005 500006 500007 500010 500011 500012 500013 AR022000 00001 500002 500005 AR035010 20502 20503 AR025006 AR025005 AR031004 568811961AR031031 568811961AR031049 00003 00004 500002;
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information Contact Maryanna Krivak
973-709-7483
Manufacturer Reason
for Recall		 Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.
FDA Determined
Cause 2		 Process change control
Action On May 6, 2022, the firm notified affected customers through an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily inspections per the IFU, which include checking for any chipped or missing paint. If you observe paint chipping or detachment, the firm recommends that you stop using the device and contact your Getinge service representative to schedule an appointment to replace the part free of charge. The firm is requesting that customers contact their Getinge service representative to have the part replaced if chipped or missing paint is observed through April 2025. Getinge service representatives will inspect the affected component during periodic maintenance and will replace the component if the issue is observed through April 2025.
Quantity in Commerce 337 (US); 8594 (OUS)
Distribution Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = MAQUET SAS
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