Smiths Medical is recalling 60,146 Medfusion Model 4000 syringe infusion pumps due to multiple software issues that can cause therapy interruptions or incorrect dosing. The defects include alarms that fail to sound, incorrect dose displays, and unexpected stops in medication delivery during bolus or loading doses. These pumps are used in healthcare settings to deliver precise amounts of fluids such as blood, lipids, and drugs. Smiths Medical has released software updates to correct these issues and advises facilities to ensure their devices are running the most recent software versions.
Failure of the software can lead to over-infusion or under-infusion of critical medications, as well as delays in therapy. These malfunctions can cause serious health complications or death, particularly in vulnerable patients such as infants or those in intensive care who rely on precise drug delivery.
Software Update
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.