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Showing 1–12 of 119 recalls
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.