Murilo Freitas – Page 34 – PRAIS 2.0

IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug

Murilo Freitas - 04:00, 1 de October de 2024242

IPV Phasitron 5 In-Line Valve helps provide therapy to promote ventilation. Users need to remove the expiratory port plug before direct ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/ipv-therapy-device-correction-sentecpercussionaire-updates-use-instructions-phasitron-5-line-valve

FDA Roundup: October 1, 2024

Murilo Freitas - 18:40, 30 de September de 2024229

FDA Roundup: October 1, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-october-1-2024

FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect

Murilo Freitas - 13:32, 30 de September de 2024265

FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
http://www.fda.gov/news-events/press-announcements/fdas-unified-human-foods-program-new-model-field-operations-and-other-modernization-efforts-go

Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy

Murilo Freitas - 04:00, 30 de September de 2024254

Ivenix LVP allows for controlled administration of large volumes of fluids but software anomalies may lead to delay or underdosing of therapy.

http://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-fresenius-kabi-usa-llc-issues-correction-ivenix-infusion-system

Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation

Murilo Freitas - 04:00, 30 de September de 2024183

Trilogy Evo, EV300, EvoO2 and Evo Universal ventilators support patient breathing. A mandatory software correction was issued to address previously reported issues.

http://www.fda.gov/medical-devices/medical-device-recalls/ventilator-software-correction-philips-respironics-issues-mandatory-software-correction-and-updates

Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

Murilo Freitas - 04:00, 29 de September de 2024244

paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators. The tidal volume knob may move out of the set position.

http://www.fda.gov/medical-devices/medical-device-recalls/ventilator-correction-smiths-medical-issues-correction-parapac-plus-p300-and-p310-ventilators-due

FDA Roundup: September 27, 2024

Murilo Freitas - 20:24, 26 de September de 2024400

FDA Roundup: September 27, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-27-2024

FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia

Murilo Freitas - 22:40, 25 de September de 2024309

FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
http://www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism-action-treatment-schizophrenia

Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture – FDA Safety Communication

Murilo Freitas - 04:00, 25 de September de 2024269

Read the FDA’s recommendations related to the Zimmer Biomet CPT Hip System and increased risk of thigh bone fracture.

http://www.fda.gov/medical-devices/safety-communications/zimmer-biomet-cpt-hip-system-femoral-stem-and-increased-risk-thigh-bone-fracture-fda-safety

FDA Approves New Drug to Treat Niemann-Pick Disease, Type C

Murilo Freitas - 21:30, 23 de September de 2024254

FDA Approves New Drug to Treat Niemann-Pick Disease, Type C
http://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-niemann-pick-disease-type-c

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