Device product
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Z-1867-2025
Product summary
- Firm
- Zyno Medical LLC
- Event
- Event 96796
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 613 units
- Official record key
device-enforcement:Z-1867-2025
Official wording
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Code information: Model Number: Z800W; UDI-DI; 00814371020020; Serial No. 700063; 700163; 700203; 700402; 700488; 700093; 700169; 700210; 700428; 700495; 700104; 700172; 700214; 700431; 700503; 700111; 700188; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Unreleased software versions were installed on distributed devices without verification or validation.