Smiths Medical ASD Inc. recalled its Medfusion 4000 syringe pump after its latest software update introduced an issue with the device.
The recent update to the syringe pump, which is used to administer blood and medicine into patients in a controlled manner, can potentially stop the syringe, giving low battery notifications to users.
The U.S. Food and Drug Administration has tagged the recall as class I, known as the most serious type of recall, as any interruption in therapy using the syringe can cause serious injury, adverse events or death.
The Weston, Mass.-based medical-device maker received 74 complaints regarding the software issue. No deaths or injuries have been reported.