Maquet Cardiovascular Us Sales, Llc
46 recalls on record · Latest: Dec 23, 2020
FDA Devices Moderate Dec 23, 2020
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used wit…
FDA Devices Moderate Dec 23, 2020
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the…
FDA Devices Moderate Oct 28, 2020
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical intervention…
FDA Devices Moderate Oct 28, 2020
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well …
FDA Devices Low Sep 23, 2020
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a met…
FDA Devices Moderate Apr 8, 2020
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
FDA Devices Moderate Mar 18, 2020
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
FDA Devices Low Mar 4, 2020
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments,…
FDA Devices Moderate Dec 18, 2019
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
FDA Devices Moderate Sep 25, 2019
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
FDA Devices Moderate Jul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
FDA Devices Moderate Jun 19, 2019
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector i…
FDA Devices Moderate Jun 19, 2019
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is desig…
FDA Devices Moderate Jun 12, 2019
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 7…
FDA Devices Critical Apr 3, 2019
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the dispos…
FDA Devices Critical Dec 5, 2018
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane…
FDA Devices Moderate Nov 9, 2016
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood he…
FDA Devices Moderate Sep 14, 2016
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room ta…
FDA Devices Moderate Apr 20, 2016
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
FDA Devices Moderate Apr 20, 2016
QUADROX-i oxygenators Custom tubing packs for the oxygenator
FDA Devices Moderate Apr 20, 2016
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
FDA Devices Moderate Nov 18, 2015
Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elem…
FDA Devices Moderate Nov 18, 2015
Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Po…
FDA Devices Moderate Jul 29, 2015
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
FDA Devices Moderate Jul 15, 2015
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical …
FDA Devices Critical Jun 17, 2015
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populat…
FDA Devices Moderate Jun 3, 2015
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extrac…
FDA Devices Moderate Dec 31, 2014
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with…
FDA Devices Moderate Nov 19, 2014
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass c…
FDA Devices Moderate Feb 5, 2014
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the spec…
FDA Devices Moderate Oct 2, 2013
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators a…
FDA Devices Moderate Jul 10, 2013
MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedur…
FDA Devices Moderate Jul 3, 2013
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorpor…
FDA Devices Critical May 8, 2013
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator S…
FDA Devices Moderate Nov 7, 2012
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The Q…
FDA Devices Critical Jul 18, 2012