Smith Medical Recalls Medfusion 4000 Syringe Pump Due to its Software Failure

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• Smith Medical has recalled its Medfusion 4000 syringe pump with firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy. The FDA has labeled it as Class I recall
• The 627 devices have recalled having model numbers are 4000-0107-01 and 4000-0106-01, manufactured on Jun 25, 2019, and distributed b/w Sept 27, 2019, and Oct 31, 2019. The company has received 74 complaints related to software update while no injuries and death have been reported
• The Medfusion 4000 syringe pump is used to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner. The malfunctioning in the battery alarm, the HCPs using the pump will not receive audible/ visual notification that the battery is shutting down which may lead to an interruption of therapy causing serious injury, AEs or death

Click here to read full press release/ article | Ref: The US FDA | Image: Signbox