Device product
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
Z-2503-2024
Product summary
- Event
- Event 94947
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-2503-2024
Official wording
Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Code information: UDI: 10885403512568/ Serial Number: 16210468 16274000 16232272 16209954 16209953 16097230 16184767 16101319 16095341 16112043 15815836 15631124 15632972 15937573 16073534 16173241
Distribution pattern: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Derived failure modes
-
Device software or design
software issue