- Baxter Healthcare has recalled two of its infusion pump products due to software issues that caused the devices to issue false alarms1234. The US Food and Drug Administration (FDA) has classified this as a Class I recall, indicating risk of injury or death with continued use of the devices1. The recalled products are SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)234. Baxter has previously recalled three of its infusion pumps in 2020 due to unplanned device shutdowns5.Learn more:✕This summary was generated using AI based on multiple online sources. To view the original source information, use the "Learn more" links.Baxter Healthcare has recalled two of its infusion pump products after software issues meant the devices were issuing false alarms. The US Food and Drug Administration (FDA) tagged this as a Class I recall, indicating risk of injury or death with continued use of the devices.www.medicaldevice-network.com/news/baxter-reca…Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased reports of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively.www.fda.gov/medical-devices/medical-device-recal…Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events.www.fda.gov/medical-devices/medical-device-recal…Baxter is recalling two of its infusion pumps due to a risk that the devices could give a false alarm for an upstream occlusion, or tubing blockage, interrupting or delaying treatment.www.medtechdive.com/news/baxter-infusion-pum…In 2020, Baxter recalled three of its infusion pumps due to unplanned device shutdowns. According to the company, improper cleaning of the devices could lead to corrosion or residue build-up, which could result in an unplanned shutdown if the device is running on battery power.www.medtechdive.com/news/baxter-infusion-pum…
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