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

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

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

Shots:

  • 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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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