FDA-Device2024-10-16Class I
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Zyno Medical LLC
Hazard
There is a defect in the air-in-line software algorithm.
Sold states
US Nationwide.
Affected count
34,994 units (1819 units still need correction)
Manufactured in
177 Pine St, Natick, MA, United States
Products
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0005-2025Don't want to check this manually?
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