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. False upstream occlusion alarms cause interrupted or delayed therapy and contribute to clinician fatigue, which may cause serious adverse health consequences, especially for people receiving life-sustaining medications.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
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