This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type.
This device may cause serious injury or death if you continue to use it. Zyno Medical stated that certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps were released to customers with incorrect software versions that had not undergone required verification and validation testing. As a result, these pumps can experience unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention.