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All product recalls associated with Mizuho Orthopedic Systems Inc.
No recalls found
Mizuho Orthopedic Systems Inc has no recalls in our database. This does not guarantee all products are safe—always check official sources.
Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
Sterility of some units may be compromised due to damaged packaging.
Sterility of some units may be compromised due to damaged packaging.
Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.
Patient Scale may become detached, which can cause a patient to fall and result in injury.
Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system.
The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
The chain holding the device gantry in position may break.
The battery may turn the pump off without warning due to a design change in the battery.
Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker
These smoke hoods are one-time use respiratory devices that assist users with breathing, while escaping a fire. They include a transparent plastic hood that covers the user's head, and a canister that filters out toxic gases. "EVAC+™" or "EVAC-U8™" is printed on the canister.
Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.
Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.
Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.
Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia