ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions

January 17, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

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Updated recommendations to help prevent the spread of infection associated with the use of these devices.

Source:Full Article

Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

January 14, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017

Source:Full Article

Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use

January 13, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.

Source:Full Article

PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer

January 12, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.

Source:Full Article

Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall - Particulates Generated in Vial

January 11, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.

Source:Full Article

Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions

January 11, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.

Source:Full Article

Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified

January 9, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.

Source:Full Article

Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified

January 9, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.

Source:Full Article

Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified

January 9, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.

Source:Full Article

Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified

January 9, 2017 by RecallAware · Leave a Comment
Filed under: Medicine 

These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.

Source:Full Article

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