Device product
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Z-1617-2023
Product summary
- Firm
- OmniCell, Inc.
- Event
- Event 92136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1617-2023
Official wording
Reason: IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
Code information: UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
Distribution pattern: AL, NY
Derived failure modes
-
Unknown
IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling