Fresenius Kabi Recalls Ivenix Infusion Systems LVP Software
Fresenius Kabi is recalling their Ivenix Infusion System LVP software due to serious anomalies that could harm patients, necessitating an urgent update to version 5.9.1.
Fresenius Kabi is recalling their Ivenix Infusion System LVP software due to serious anomalies that could harm patients, necessitating an urgent update to version 5.9.1.
The Government Accountability Office (GAO) is launching an investigation into the U.S. FDA's potentially ineffective policies for recalling medical devices, prompted by concerns raised by Senators Durbin and Blumenthal regarding the slow response to recalls of Philips Respironics CPAPs, BiPAPs, and mechanical ventilators.
B. Braun Medical, Inc. is recalling the Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms that may lead to interruptions in the delivery of high-risk medications, potentially causing serious harm or death, with 51 complaints, one injury, and one death reported.
Fresenius Kabi is recalling their Ivenix Infusion System LVP software due to serious anomalies that could harm patients, necessitating an urgent update to version 5.9.1.
Abiomed issued the recall because the pumps’ instructions for use do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement.
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Read MoreThe FDA received an additional 6,000 medical device reports January 1, 2023-March 31, 2023, related to PE-PUR foam used in Philips ventilators and other devices recalled in June 2021.
Read MoreThese infusion system replacement batteries were recalled because a defect has diminished how long they can be used to run the system, which may cause the system to shut down an ongoing infusion.
Read MoreECRI has announced the winners of its 2023 Alerts Impact Award, recognizing members of its Alerts Workflow solution for their outstanding implementation of recall management programs in healthcare organizations.
Read MoreRRD's solution aims to ensure end-to-end support throughout the complex recall notification process for medical device companies.