Medical equipment, implants, and diagnostic devices
Siemens Medical Solutions USA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Dental EZ Group Star Dental Division
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Siemens Medical Solutions USA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Siemens Medical Solutions USA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Inspire Medical Systems
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Medtronic
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Potential for coils to heat up and harm patients (burn).
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Exactech
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.