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 process. The historical review determined that some of the risk evaluations conducted in the past did not fully account for all the risks associated with the issues. After re-evaluating the patient risk, Smiths Medical determined that the issues identified were associated with sufficient patient risk that it is necessary to notify users, even if the remediation for an issue was available in previous software versions. Recall start date: November 7, 2023
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