Device product
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Z-1018-2022
Product summary
- Event
- Event 89896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 systems
- Official record key
device-enforcement:Z-1018-2022
Official wording
Reason: When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
Code information: All systems running BD Synapsys version 4.10; UDI: 00382904441500; Serial Numbers: SL00530 SL00515 SL00527 SL00502 SL00540 SL00564 SL00549 SL00509 SL00003 SL00004 SL00010 SL00001 SL00005 SL00002 SL000015 SL01010 SL01022
Distribution pattern: Worldwide distribution US Nationwide distribution in the states of CA, IL, MI, NY, OH, SC, and TN. The countries of Austria, France, Germany, Netherlands, Sweden.
Derived failure modes
-
Unknown
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.