Device product
Baxter Exactamix Pro 1200, REF EXM12DY
Z-1001-2024
Product summary
- Event
- Event 93700
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 8 devices
- Official record key
device-enforcement:Z-1001-2024
Official wording
Reason: An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
Code information: UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005
Distribution pattern: US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
Derived failure modes
-
Device software or design
error was identified in software