Device product
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Z-2334-2025
Product summary
- Event
- Event 97296
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 22703 units
- Official record key
device-enforcement:Z-2334-2025
Official wording
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Code information: UDI/DI N/A, All Serial Numbers
Distribution pattern: US distribution including Puerto Rico and OUS (International) Canada
Derived failure modes
-
Device software or design
software anomalies