Baxter Healthcare issues urgent correction for Novum IQ Syringe Pump software anomalies
Baxter Healthcare is issuing an urgent correction for the Novum IQ Syringe Pump due to software anomalies that may display a blank run screen or generate false motor movement errors. The correction affects 10,101 units distributed in the US, Puerto Rico, and Canada.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This device is classified as FDA Class I, which indicates a serious potential for harm. Although no illnesses or injuries have been reported, the software anomalies affecting this infusion pump—which may cause blank display screens or false motor error messages—directly impact the safe operation of a critical medical device used for patient medication delivery.
Plain-English summary
Baxter Healthcare Corporation is issuing an urgent medical device correction for the Novum IQ Syringe Pump. The correction addresses software anomalies that may result in a blank Run screen and/or false motor movement system errors.
The affected device (Product Code 40800BAXUS, UDI/DI 05413765852428) has 10,101 units in distribution across the United States, including Puerto Rico, and in Canada. All serial numbers of the affected devices are involved in this correction.
Users of the Novum IQ Syringe Pump should reference Baxter Healthcare's urgent medical device correction notice for specific information about the software anomalies and recommended actions.
The recalled product
- Product
- Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- software-anomaly
- display-failure
- motor-control-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 05413765852428
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
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