FDA Issues Alert for GE HealthCare Patient Monitoring Software Issue
The issue involves the Portrait Mobile Monitoring Solution and could lead to patients being removed from the system or alarm settings resetting during updates.
Category: Recalls
Recalls
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Recalls
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Medical Device Recalls Declined in Q1 2026 Amid FDA Quality System Changes
Sedgwick’s latest report shows fewer medical device recall events in Q1 2026, while sterility-related recalls drove the majority of impacted units.
Recalls
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Baxter Removes Sigma Spectrum Infusion System Platforms
The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.
Recalls
Latest
FDA Issues Alert for GE HealthCare Patient Monitoring Software Issue
The issue involves the Portrait Mobile Monitoring Solution and could lead to patients being removed from the system or alarm settings resetting during updates.
NOxBOXi Delivery System Correction Issued After Reports of Nitric Oxide Dose Fluctuations
The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.Â
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Siemens Healthineers Corrects 3 Tesla MRI Systems Over Magnet Venting Blockage Risk
The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.
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FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set
The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.
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3M Company Corrects Ranger Blood/Fluid Warming System
The action addresses a discrepancy between the device’s labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
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FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
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Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
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Recalls
Latest
Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
