Tag: FDA recall

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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.

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FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits

The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.

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FDA Flags Recall Involving IMRIS MRI Systems Linked to Siemens 3T Magnet Issue

The recall affects IMPRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.

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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.

FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set

Nov 20, 2025

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.

ECRI Announces Winners of 2025 Alerts Impact Award

Nov 4, 2025

The annual award recognizes excellence in recall management among healthcare institutions worldwide.

FDA Expands Early Alert Program for High-Risk Device Issues

Sep 30, 2025

The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.

FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller

Sep 23, 2025

The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.

Class I Recall Expanded for Alaris Pump Infusion Sets

Sep 18, 2025

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.

Tandem Issues Correction for t:slim X2 Insulin Pumps

Sep 15, 2025

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.

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Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error

Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.