Medical equipment, implants, and diagnostic devices
Varian Medical Systems
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
Integra LifeSciences
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.
Integra LifeSciences
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Integra LifeSciences
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Varian Medical Systems, Inc. Oncology Systems
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.