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Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation.
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FDA Roundup: May 10, 2024
FDA Roundup: May 10, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024
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OPS pide a países del hemisferio sur prepararse para posible aumento de enfermedades respiratorias y el dengue
PAHO urges countries in the Southern Hemisphere to prepare for possible increase in respiratory diseases and dengue
Cristina Mitchell
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Caribbean Mosquito Awareness Week 2024: PAHO calls to unite against dengue
Caribbean Mosquito Awareness Week 2024: PAHO calls to unite against dengue
Cristina Mitchell
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MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode
MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on
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Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
Route 92 Medical is recalling certain products that include Tenzing 7 Delivery Catheters due to instances of the catheter tip separating near the marker band.
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PAHO Director Concludes Visit to Jamaica
PAHO Director Concludes Visit to Jamaica
Cristina Mitchell
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FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair
FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair
http://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-clarify-remanufacturing-devices-need-maintenance-or-repair
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EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
http://www.fda.gov/news-events/press-announcements/epa-fda-and-usda-issue-joint-regulatory-plan-biotechnology
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Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery