GETINGE US SALES LLC

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0677-2020Class IIMaquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with BiolinNovember 13, 2019
Z-2559-2019Class IIThe HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft August 22, 2019
Z-2433-2019Class IIGetinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.July 22, 2019
Z-2077-2019Class IIPulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFJune 5, 2019
Z-1221-2019Class IIIMaquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 668March 20, 2019
Z-0988-2019Class IIMaquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A January 8, 2019
Z-0989-2019Class IIMaquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400January 8, 2019
Z-0987-2019Class IIMaquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product UsJanuary 8, 2019
Z-0990-2019Class IIMaquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A PrJanuary 8, 2019
Z-1349-2018Class IIVOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD56February 7, 2018
Z-1172-2018Class IIHEMASHIELD Knitted Double Velour Cardiovascular FabricJanuary 3, 2018
Z-1927-2018Class IIALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the eNovember 16, 2017