Getinge Usa Sales Inc Recall 90305
Description: 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
Getinge Usa Sales Inc Recall 90305 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1308-2022 |
| Event ID | 90305 |
| Event Description | 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 |
| Product Type | Devices |
| 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. |
| Quantity | 265 (US); 8594 (OUS) |
| Recall Reason | 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. |
| Device Classification | 20220706 |
| Device Code Info | 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: 22000 25002 38017 38005 20503 20502 31031 31049 20500 500002 510003 510060 510061 510062 21001 21002 31003 31002 31012 31009 31001 31010 31006 31000 31004 31008 31017 31018 31019 31021 31026 31025 31020 31024 31022 31023 35000 35001 35011 35012 35013 35015 35014 35026 35017 35030 35031 35032 35033 35020 35024 35022 35023 35027 35019 35021 35028 35018 35025 38001 38003 38000 38002 38013 38015 38012 38011 38016 38014 38009 38020 38021 38018 38019 38025 38022 38023 38026 38027 25004 25006 25005 25007 28004 28003 31008 31003 31001 31000 31002 31004 31009 31011 31005 31006 31016 31015 31020 31012 31013 31014 31019 31017 31030 31041 31055 31056 31046 31044 31043 31045 31042 31040 31039 31054 31051 31052 31047 31048 31050 31053 38028 38027 38025 38026 500000 500001 500000 500007 500008 500001 500000 500005 500003 500018 500017 500002 500004 500003 500005 500006 500007 500020 500022 500019 500021 500010 500011 500008 500007 500042 500045 500044 500040 500043 500041 500012 500046 500055 500050 500049 500007 500006 500005 500004 500062 500013 500011 500012 500010 500008 500009 500024 500069 500021 500020 500025 500022 500026 500028 500027 500028 500027 500029 500030 550036 500017 500033 500032 500019 500020 500026 500034 500004 500006 500005 550058 510002 510004 510005 510003 510001 510002 510004 510006 510005 510011 510007 510008 510012 510009 510010 510017 550044 510019 510020 510021 510026 510027 510028 510011 510012 510013 510014 510015 510016 510017 510018 510019 510020 510021 510022 510023 510024 590362 500002 510062 510063 510064 510057 510058 510059 35010 35029 38024 25003 25002 550060 500013 500047 500003 500006 500001 510001 550059 500018 510007 510008 500027 510006 510003 500014 590610 25003 25001 |
| Center Classification Date | 20220630 |
| Recall Initiation Date | 20220506 |
| Recalling Firm | Getinge Usa Sales Inc |
| Initial Notification | Letter |
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