Device product
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
Z-0005-2025
Product summary
- Firm
- Zyno Medical LLC
- Event
- Event 95382
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 34,994 units (1819 units still need correction)
- Official record key
device-enforcement:Z-0005-2025
Official wording
Reason: There is a defect in the air-in-line software algorithm.
Code information: UDI-DI: Z-800 - 00814371020006 Z-800W - 00814371020020 Z-800F - 00814371020013 Z-800WF - 00814371020037 Lot Numbers: 190722360 20110921-SH 20111005-SH 20111102-SH 20111212-SH 20120105-SH 20120222-SH 20120501-SH 20120612-SH 20120719-SH 20120809-SH 20190809-SH 20120910-SH-1 20121213-sh 20130123-SH 20130227-SH 20120417-SH 20130511-SH 20130517-SH 20130609-SH 20130701-SH 20130812-SH 20131024-SH
Distribution pattern: US Nationwide.
Derived failure modes
-
Device software or design
defect in the air-in-line software