Mizuho OSI

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1573-2022Class IIHANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144July 29, 2021
Z-1293-2021Class IIMizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control UnitFebruary 8, 2021
Z-0091-2021Class IILevo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-05October 14, 2019
Z-1867-2017Class II216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G March 28, 2017
Z-0792-2016Class IIMizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP December 14, 2015
Z-0810-2013Class IIMizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.December 17, 2012