Device product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Z-1304-2025
Product summary
- Event
- Event 96323
- Status
- Ongoing
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1304-2025
Official wording
Reason: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Code information: Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)
Distribution pattern: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
Derived failure modes
-
Device software or design
Software issue