Maquet

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
7
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2420-2025Class IICorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 7July 14, 2025
Z-2502-2018Class IIVOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QLJune 14, 2018
Z-1937-2018Class IIVOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with April 19, 2018
Z-0490-2018Class IIHemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracMay 22, 2017
Z-0627-2013Class IIMaquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 7643November 2, 2012
Z-2210-2012Class IIMaquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 May 29, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K214120GSS610N21 Series Steam SterilizerMay 18, 2022
K201927Getinge GSS610N Series Steam SterilizerMarch 1, 2021
K172159Getinge GSS67N Series Steam SterilizerJanuary 30, 2018
K130513VOLISTA 400; VOLISTA 600May 8, 2013
K113679LUCEA LED SURGICAL LIGHT SYSTEMJanuary 12, 2012
K070442POWERLED SURGICAL LIGHT SYSTEMMarch 16, 2007
K030071SERVO GUARD, MODEL 64 81 290 EH88EApril 26, 2004