Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017 Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model. Posted 01/13/2017 PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. Posted 01/12/2017 Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall - Particulates Generated in Vial The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death. Posted 01/11/2017 Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam. Posted 01/11/2016 Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified 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. Posted 01/09/2017 I.V. Flush Syringes by Nurse Assist: Recall - Potential Link to Burkholderia Cepacia Bloodstream Infections UPDATED 01/04/2017 Recall classified as Class I. The effects of Burkholderia cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis. Originally Posted 10/05/2016
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