Device product
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Z-1119-2025
Product summary
- Event
- Event 96055
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 137,741 total
- Official record key
device-enforcement:Z-1119-2025
Official wording
Reason: Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Code information: (1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected
Distribution pattern: Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
Derived failure modes
-
Device software or design
Software issues could potentially result in