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Fresenius Kabi USA, LLC Recall 93958

Description: LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Fresenius Kabi USA, LLC Recall 93958 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1282-2024
Event ID93958
Event DescriptionLVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Product TypeDevices
DistributionUS Nationwide distribution in the states of WI and NJ.
Recall ReasonRetroactively 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 (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
Device Classification20240320
Device Code InfoUDI-DI 00811505030122 Software versions 5.0.1 and earlier.
Center Classification Date20240311
Recall Initiation Date20220916
Recalling FirmFresenius Kabi USA, LLC
Initial Notification Other
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