50 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
FDA Enforcement
Class II
·Terminated·Maquet SAS·June 6, 2018
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
FDA Enforcement
Class II
·Terminated·Maquet SAS·July 25, 2018
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·October 30, 2013
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·February 23, 2009
ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·February 23, 2009
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
FDA Recall
Terminated
·Maquet SAS Parc De Limere Avenue De La Pomme De Pin Orleans France·Product code FTD·June 14, 2018
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
FDA Recall
Terminated
·Maquet SAS Parc De Limere Avenue De La Pomme De Pin Orleans France·Product code FTD·April 19, 2018