Maquet Cardiovascular Us Sales, Llc

FDA Regulatory Profile

Summary

Total Recalls
62 (7 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0633-2021Class IIHLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794November 20, 2020
Z-0632-2021Class IIHLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105November 20, 2020
Z-0443-2021Class IIBlood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters September 30, 2020
Z-0132-2021Class IIYuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediateSeptember 24, 2020
Z-0133-2021Class IIYuno II Mobile Operating Table - Product Usage: support and position the patient immediately before,September 24, 2020
Z-2957-2020Class IIIMaquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - CeAugust 7, 2020
Z-2780-2020Class IIHolder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number:June 18, 2020
Z-1603-2020Class IIAvalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039February 20, 2020
Z-1475-2020Class IIGetinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: February 10, 2020
Z-1391-2020Class IIIGetinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilJanuary 16, 2020
Z-1390-2020Class IIIGetinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilJanuary 16, 2020
Z-0678-2020Class IIMaquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a componDecember 3, 2019
Z-2149-2019Class IIMaquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part NumbeJuly 11, 2019
Z-1863-2019Class IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SFMay 28, 2019
Z-1864-2019Class IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DFMay 28, 2019
Z-1856-2019Class IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STPMay 28, 2019
Z-1852-2019Class IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STPMay 28, 2019
Z-1859-2019Class IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIMMay 28, 2019
Z-1857-2019Class IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIMMay 28, 2019
Z-1861-2019Class IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SFMay 28, 2019