Day

March 11, 2024
11
Mar

More efficient and effective CAPA

March 11, 2024
Effective and more efficient example!
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11
Mar

FDA Recall: Software Defect May Cause an Incorrect Fail-Stop Alarm

March 11, 2024
Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 3/11/2024 Class II PRODUCT LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Recall Number: Z-1282-2024 REASON: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable...
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