Mizuho OSI Recalls
6 recalls on record · February 20, 2013 to August 31, 2022 · Medical Devices
Recalls by year
13
16
17
20
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 31, 2022Medical DevicesFDA
Mizuho OSI recalls HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Hazard: One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
March 31, 2021Medical DevicesFDA
Mizuho OSI recalls Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: in
Hazard: There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.
October 21, 2020Medical DevicesFDA
Mizuho OSI recalls Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Pro
Hazard: Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism
April 26, 2017Medical DevicesFDA
Mizuho OSI recalls 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. Genera
Hazard: Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.
February 17, 2016Medical DevicesFDA
Mizuho OSI recalls Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Ope
Hazard: Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.
February 20, 2013Medical DevicesFDA
Mizuho OSI recalls Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Hazard: Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.