Day

October 6, 2022
Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 10/6/2022 Class I PRODUCT Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 Recall Number: Z-0002-2023 REASON The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification....
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Being Agile & Yet Compliant

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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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