An earlier software version of the product, the Medfusion Model 4000 Syringe Infusion Pump, might disrupt therapy administration and affect the alarm system, pump, control screen and other parts.

On March 5, the FDA posted an alert for 85,961 Medfusion Model 3500 Syringe Infusion Pumps, and two weeks earlier, the agency published a warning related to 50,743 Model 4000 syringe pumps.

The affected devices were Medfusion 4000 Syringe Pumps with Firmware Version 1.7.0. ("Firmware" is software intended to permanently reside on a computer to make a device work.) ...

The FDA also issued a Class I recall, for devices that could cause serious injury or death, for specific lot numbers of Smiths’ Medfusion 3500 and 4000 infusion pumps in 2022.

Smiths Medical, which became partof ICU Medical in a $2.35 billion takeoverin January 2022, wrote to customers in December after identifying software problems that could cause its Medfusion 4000 ...

The US Department of Homeland Security (DHS) has warned of eight new vulnerabilities in several popular syringe infusion pump models which could allow a remote hacker to alter how they work. An ...

The new Medfusion ® 4000 pump includes enhanced and user-friendly features based on clinician usability input, including wireless (802.11b/g) and wired Ethernet capability to allow easy ...

MINNEAPOLIS-- (BUSINESS WIRE)--Smiths Medical has become aware of an issue where certain Medfusion ® 3500 and 4000 syringe pumps with firmware versions listed below may not operate as expected.

FDA inspectors found ICU Medical made multiple changes to the Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump that could significantly affect the devices ...

"The Medfusion® 4000 wireless pump represents the next-generation advancement of the popular Medfusion® 3500 syringe infusion pump, which is widely recognized for its accurate medication ...