Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Class I - Dangerous
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Class I - Dangerous
Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
Pump shutting off during use without warning.