Categories rss SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor TipMurilo Freitas - 04:00, 28 de April de 2024194 0 SonarMed Airway monitors recalled for a software issue where it fails to detect partial obstructions in 2.5mm sensors and within 3mm of sensor tip. http://www.fda.gov/medical-devices/medical-device-recalls/sonarmed-inc-recalls-airway-monitors-due-software-anomaly-resulting-failure-detect-partial
Categories rss SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage DifficultyMurilo Freitas - 04:00, 28 de April de 2024164 0 SonarMed Airway acoustic sensors recalled due to a restricted inner diameter resulting in difficulty passing a suction catheter through the sensor. http://www.fda.gov/medical-devices/medical-device-recalls/sonarmed-inc-recalls-airway-acoustic-sensors-due-restricted-inner-diameter-airway-causing-suction
Categories rss FDA Roundup: April 26, 2024Murilo Freitas - 19:08, 25 de April de 2024230 0 FDA Roundup: April 26, 2024http://www.fda.gov/news-events/press-announcements/fda-roundup-april-26-2024
Categories rss FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety CommunicationMurilo Freitas - 04:00, 25 de April de 2024236 0 These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices. http://www.fda.gov/medical-devices/safety-communications/fda-encourages-public-follow-established-choking-rescue-protocols-fda-safety-communication
Categories rss Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy NeedleMurilo Freitas - 04:00, 25 de April de 2024136 0 Elekta recalls Disposable Biopsy Needles (911933) from batch 837838839 due to potential microscopic stainless steel debris inside. http://www.fda.gov/medical-devices/medical-device-recalls/elekta-instrument-ab-recalls-disposable-biopsy-needle-kit-leksell-stereotactic-system-possibly
Categories rss Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAsMurilo Freitas - 04:00, 24 de April de 2024191 0 The Tablo Hemodialysis System may expose patients to higher than allowable levels of NDL-PCBAs. http://www.fda.gov/medical-devices/medical-device-recalls/outset-medical-inc-recalls-certain-tablo-hemodialysis-systems-risk-patient-exposure-higher-allowable
Categories rss InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and DeathMurilo Freitas - 04:00, 24 de April de 2024162 0 Nimbus and Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death. http://www.fda.gov/medical-devices/medical-device-recalls/infutronix-llc-recalls-nimbus-and-nimbus-ii-infusion-pump-systems-multiple-device-failures-may-cause
Categories rss FDA Approves New Treatment for Uncomplicated Urinary Tract InfectionsMurilo Freitas - 17:32, 23 de April de 2024177 0 FDA Approves New Treatment for Uncomplicated Urinary Tract Infectionshttp://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections
Categories rss DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse AssistMurilo Freitas - 04:00, 23 de April de 2024200 0 DeRoyal is recalling Surgical Tracecarts with Nurse Assist 16FR Silver Urine Meter Foley due to sterility concerns. Other items in the tracecart are unaffected. http://www.fda.gov/medical-devices/medical-device-recalls/deroyal-industries-inc-recalls-tracecarts-containing-16fr-urine-meter-foley-under-recall-nurse
Categories rss FDA Roundup: April 23, 2024Murilo Freitas - 19:20, 22 de April de 2024225 0 FDA Roundup: April 23, 2024http://www.fda.gov/news-events/press-announcements/fda-roundup-april-23-2024
