LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Reported: March 20, 2024 Initiated: September 16, 2022 #Z-1282-2024
Product Description
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Reason for Recall
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 (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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 3
- Distribution
- US Nationwide distribution in the states of WI and NJ.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004. Recalled by Fresenius Kabi USA, LLC. Units affected: 3.
Why was this product recalled? ▼
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 (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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2024. Severity: Moderate. Recall number: Z-1282-2024.
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