Mizuho OSI

6 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Surgical Instruments

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Class I - Dangerous

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

Jul 29, 2021 Other Medical Devices Nationwide View Details →

Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

Class I - Dangerous

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.

Feb 8, 2021 Surgical Instruments Nationwide View Details →

Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

Class I - Dangerous

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

Oct 14, 2019 Other Medical Devices Nationwide View Details →

216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

Class I - Dangerous

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.

Mar 28, 2017 Other Medical Devices View Details →

Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

Class I - Dangerous

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.

Dec 14, 2015 Other Medical Devices View Details →

Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

Class I - Dangerous

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.

Dec 17, 2012 Other Medical Devices Nationwide View Details →