Smiths Medical recalls Medfusion 4000 due to issue with software update

Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today.

The FDA has labeled the recall as Class I, it’s most serious designation.

The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner. They are used primarily in neonatal and pediatric populations in operating rooms, as well as intensive care units for adults.

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