Day

May 14, 2025
14
May

FDA Recall: Defects in the software potentially resulting in over-delivery to patient

May 14, 2025
Company: ICU Medical, Inc. Date of Enforcement Report: 5/14/2025 Class II PRODUCT LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 Recall Number: Z-1763-2025 REASON: Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values...
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