Fresenius Kabi Issues Correction for Ivenix Infusion Pumps Following Impact Damage
The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.
The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.
The company advises taking any dropped or severely jarred modules out of service and sending them to biomedical engineering for inspection before reuse.
Effective stakeholder analysis and requirements gathering are critical to safe, compliant infusion system design.
The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.
Designed for use in MRI environments, the infusion pump builds on the company’s earlier systems, which the company says remain the only non-magnetic infusion pumps cleared for use during MRI procedures.
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