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Smiths Medical identified legacy software anomalies which may occur in the Medfusion 3500 syringe infusion pumps. the legacy software anomalies were identified during a historical review of the risk evaluations conducted during the software development…

Smiths Medical identified legacy software anomalies which may occur in the Medfusion 4000 syringe infusion pumps. The legacy software anomalies were identified during a historical review of the risk evaluations conducted during the software development…

In rare cases, an ECG failure affecting impedance measurement via defibrillation electrodes has led to the Defigard Touch-7 falsely reports an electrode fault, resulting in inoperative defibrillation. Recall start date: November 14, 2023

GE Healthcare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products. This could result in a potential fall of elements of the overhead tube suspension (OTS) …

Philips has identified an issue where a specific component failure in the gradient coil of the affected 1.5T MR systems listed in this letter may act as a heat source with a potential to produce smoke and/or fire. if the component failure occurs, the…

BD is issuing a notification to inform customers that Cardinal Health branded Monoject™ syringes have not been validated for use with the BD Alaris™ infusion devices. BD has validated Covidien branded Monoject™ syringes for use with the BD Alaris™…

BD is issuing a notification to inform customers that Cardinal Health branded Monoject™ syringes have not been validated for use with the BD Alaris™ infusion devices. BD has validated Covidien branded Monoject™ syringes for use with the BD Alaris™…

Olympus is providing updated warning and recommendations after being aware of patients suffering complications from over insufflation including arrythmias, gas embolism, and death during surgical procedures. Recall start date: October 13, 2023

The manufacturer received three reports that during processing and preparation of the room setup the monitor suspension disconnected from the height adjustable arm construction. This affects all lots of the lightweight spring arm (part numbers 42A-43L,…

At the end of August 2022, Fresenius complaint handling unit (Germany) registered a complaint from New Zealand that an infant (no day fill) developed iodine induced hypothyroidism following use of stay safe disinfection cap. Further investigations…

During a complaint investigation it was reported that the rotation of the Cardiohelp Emergency Drive hand crank was blocked or impaired. In course of internal investigations, it was found that the safety washer causes this issue. The safety washer was…

Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures and inquiries from the FDA regarding these reports. Olympus is reminding users to closely follow reprocessing instructions, including periodic…

Due to a software issue, Sapphire Infusion Pump with SW Version 16.10.1 and 16.10.2 may sometimes fail to identify air in line (AIL). AIL may lead to air embolism. No complaints or patient harm has been reported due to this issue. Recall start Date:…

We have become aware of a malfunction with the Hamilton-C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal patient group without a restart of the device, the device…

Epiphany, now a Baxter Healthcare company, is issuing an urgent medical device correction for the Cardio Server E3 ECG Management System Software due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used…