Baxter Spectrum IQ Infusion System Recalled for Programming Error
Baxter is recalling Spectrum IQ Infusion Systems because a software error prevents operators from programming certain infusions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software error that prevents programming rather than a defect causing direct physical injury or death, fitting the criteria for a moderate severity issue.
Plain-English summary
Baxter Healthcare Corporation is recalling 354 units of the SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, model 3570009. The recall covers units distributed in New Jersey with UDI 00085412610900 and serial numbers distributed prior to July 9, 2018.
The recall was initiated because a software defect causes the device to display a false "hard limit exceeded" error. This error occurs when an operator attempts to manually program a Basic Infusion for a drug not included in the Drug Library using Basic-Dose Mode, which prevents the infusion from being programmed.
Healthcare facilities and operators should stop using the affected devices and contact Baxter Healthcare Corporation for instructions on replacement or repair.
The recalled product
- Product
- SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 354
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 (1)
- UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
Distribution
Distributed in 1 state:
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