Categories
Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation.
Categories
FDA Roundup: May 10, 2024
FDA Roundup: May 10, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024
Categories
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
Categories
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.
Categories
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
Categories
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
Categories
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
Categories
Safety and Quality Concerns with Getinge Cardiovascular Devices – Letter to Health Care Providers
Health care providers and facilities should begin to transition away from these devices and seek alternatives.
Categories
FDA Roundup: May 7, 2024
FDA Roundup: May 7, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024
Categories
FDA Roundup: May 3, 2024
FDA Roundup: May 3, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-may-3-2024