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 ARDV
Check against the official notice below — it lists the full affected range.
Getinge USA Sales Inc. is recalling VOLISTA StandOP Surgical Lights due to a hazard where paint particles may detach and fall into the operating field during surgery. If paint particles enter a patient's body or the surgical field, they could potentially cause infection, organ irritation, hypersensitivity reaction, or tissue granuloma. The affected surgical lights include multiple product codes and models (VLT600SF, VLT600DF, VLT400DF, VST60, VST40, and VST66 variants) with a total of 337 units distributed in the United States across 22 states and 8,594 units distributed outside the U.S.
The recall notice identifies specific product codes, model numbers, and serial numbers for the affected surgical lights. However, the source document does not specify a remedy or action that consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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: 337 (US); 8594 (OUS) Lot/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: 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 AR035
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.