Infusion pump software anomalies may cause blank screens and false alerts
Baxter Healthcare recalls Novum IQ infusion pumps due to software anomalies that may cause blank display screens or false motor movement alerts. 43,922 units affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification for an infusion pump with software anomalies. The agency's Class I designation indicates potential for serious patient harm and meets the Critical severity criterion.
Plain-English summary
The Novum IQ Large Volume Pump (LVP) and Syringe Pump (SP) are infusion devices manufactured by Baxter Healthcare Corporation. An FDA Class I recall has been issued due to software anomalies in these pumps.
The software anomalies may result in a blank Run screen on both the LVP and SP, or false motor movement system error messages on the SP model.
The recall affects 43,922 units distributed in the United States (including Puerto Rico) and Canada. All serial numbers of these products are included. Baxter Healthcare Corporation has issued an Urgent Medical Device Correction for this matter.
The recalled product
- Product
- Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- software-anomaly
- blank-display
- false-motor-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 05413765851797
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
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