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Recall Observatory FDA recall evidence

Device product

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

Z-1183-2024

December 20, 2023

Class II

Product summary

Firm
Zyno Medical LLC
Event
Event 93857
Status
Ongoing
Classification
Class II
Quantity
574 units
Official record key
device-enforcement:Z-1183-2024

Official wording

Reason: When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death

Code information: UDI: 00814371020037 software version 5.2.05

Distribution pattern: Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software version 5.2.05, the alarm volume may