VOCSN V+Pro Ventilators Recalled by React Health
React Health is removing certain VOCSN V+Pro units due to a potential oxygen leak condition prior to or during ventilation.
Category: Recalls & Advisories
Recalls & Advisories
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VOCSN V+Pro Ventilators Recalled by React Health
React Health is removing certain VOCSN V+Pro units due to a potential oxygen leak condition prior to or during ventilation.
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Draeger Expands Corrections for Atlan A350 and A350 XL Anesthesia Workstations
A manufacturing error in the ventilator motor assembly may cause mechanical ventilation to fail before or during use, according to an FDA early alert.
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CMS/FDA Launch New Pathway to Fast-Track Medicare Access for Medical Devices
The RAPID coverage pathway aims to reduce delays between FDA authorization and Medicare coverage for breakthrough technologies.
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FDA Launches Real-Time Clinical Trial Initiative
The FDA is testing a new framework for monitoring safety signals as trials progress to reduce...
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Philips Issues New Ventilator Correction
Philips has issued a recall for Trilogy ventilators be corrected prior to continued use, according to an FDA alert. The alert includes Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal devices.
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FDA Replaces Adverse Event Reporting Systems
The FDA launched its Adverse Event Monitoring System (AEMS), a new unified platform that allows reports for drugs, biologics, vaccines, cosmetics, and animal food to be displayed in a single streamlined dashboard.
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FDA Eliminates Limitation on Real-World Evidence
The US FDA removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews.
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Corrections for GE HealthCare Carestation Anesthesia Systems
GE HealthCare issued updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems due to the potential for an unexpected shutdown, the FDA reports.
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Baxter Permanently Removes Life2000 Ventilation System
Baxter is recalling the Life2000 Ventilation System due to a cybersecurity issue discovered through internal testing, the FDA reports.
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Medline Issues Correction for Kits with Flexicare BritePro Laryngoscope Handles
Medline Industries updated instructions for medical convenience kits containing the Flexicare BritePro Solo Fiber Optic Laryngoscope Handles.
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Intersurgical Recalls i-View Video Laryngoscope
Intersurgical Inc is recalling the i-View Video Laryngoscope due to power and battery issues, according to an FDA alert.
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Additional Correction for NOxBOXi Due to Dosing Fluctuations
Customers reported fluctuations in the monitored nitric oxide value (over ±20% of the set dose) when the NOxBOXi system is used with specific settings on the Bunnell LifePulse ventilator.
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Correction Issued for NOxBOXi Nitric Oxide System Due to Button Pushing
A correction was issued to alert users not to rapidly push buttons when operating the NOxBOXi Nitric Oxide Delivery System.
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FDA Targets Unauthorized Anti-Choking Devices
The FDA issued import alerts and warning letters to companies marketing unauthorized anti-choking devices.
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Olympus Recalls Certain ViziShot 2 Flex Needles
Olympus recalled certain ViziShot 2 Flex (19G) products due to a potential patient safety issue caused by potentially deformed a-traumatic tips, according to the FDA.
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FDA Warns Against Using Unauthorized Infant Monitors
The US FDA is warning consumers, caregivers, and healthcare providers of risks related to using unauthorized infant monitors for measuring and monitoring vital signs.
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Philips Respironics Recalls DreamStation Auto CPAP, Auto BiPAP Devices
Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices, according to a September 12th FDA alert.
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FDA Calls for Child-resistant Packaging on Nicotine Pouches
The proliferation of nicotine pouch ingestions by children has prompted the FDA to call for child-resistant packaging for all products.
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Hamilton Medical Recalls Coaxial Breathing Circuit Set
Hamilton Medical is recalling certain lots of coaxial breathing sets used to connect Hamilton ventilators to a patient tube or respiratory mask during ventilation, according to an FDA alert.
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Ambu Recalls Spur II Manual Resuscitators
Ambu Inc is recalling Spur II manual resuscitators due to the manometer port being blocked, which renders the manometer non-functional, according to an FDA alert.
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Hamilton Medical Recalls C6 Ventilators
Hamilton Medical issued an Urgent Medical Device Correction letter for its Hamilton-C6 ventilators due to an issue that may prevent startup or cause the ventilator to enter an ambient state during use, interrupting ventilation, according to an FDA alert.
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FDA Warns of Fire Risks Tied to Hyperbaric Oxygen Therapy
The FDA is aware of recent reports of fires related to hyperbaric oxygen therapy devices that resulted in serious injuries and deaths, but the root cause of these events is not known.
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FDA Begins Real-time Reporting of Adverse Event Data
The US FDA has begun daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS).
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Dräger Recalls SafeStar and TwinStar Filters
Dräger SafeStar and TwinStar filters are bidirectional breathing system filters used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination.
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