🏥 Medical Devices • 15,809 recalls
Boston Scientific Neuromodulation
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Canon Medical System, USA
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
Canon Medical System, USA
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
Boston Scientific Neuromodulation
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Boston Scientific Neuromodulation
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
Boston Scientific Neuromodulation
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Boston Scientific Neuromodulation
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Medtronic Navigation
Product was incorrectly assembled which could affect navigation accuracy of the device.
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Biomet
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Siemens Medical Solutions USA
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Biomet
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Abbott Laboratories
Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a component of the LSM 700, 800 and 900 system
The firm received reports of a number of broken latches on the floorsitter.
Siemens Medical Solutions USA
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.