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Foot Stirrups may detach from mount when user is locking system
Susceptibility comments are ommited from Microbiology cumulative reports
The product was shipped prior to being sterilized.
Non-sterilized product sold as sterile.
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
Product contains an improper bracket for the transducer.
The device is not stable throughout its labeled expiration date.
The air detector may not detect air bubbles consistently at the selected limit.
patient images misidentified
Label may bear an incorrect part number [2227-02-02] and size [03.8MM].
Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.
Potential for false negative patient results with software version 3.0
Images display with wrong patient demographics.
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
Possible difficulty for the user in opening the stone retrieval basket.
If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.