Spectrum IQ Infusion System False Occlusion Alarm Correction Issued
The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The device is classified as FDA Class I, which mandates a minimum severity of Severe (4). Although no illnesses or injuries have been reported in the source text, the FDA's Class I designation reflects the seriousness of the false occlusion alarm malfunction in medical infusion equipment.
Plain-English summary
The FDA has issued a Class I medical device correction for the Spectrum IQ Infusion System with Dose IQ Safety Software, manufactured by Baxter Healthcare Corporation. The correction addresses an increase in reported false upstream occlusion alarms occurring after software upgrades to versions v8.01.01 and v9.02.01.
Approximately 19,861 units have been distributed nationwide. All serial numbers of the Spectrum IQ system are affected, as identified by UDI/DI 00085412610900 and software version v9.02.01.
Healthcare facilities using affected systems should be aware of this FDA Class I correction. Contact Baxter Healthcare Corporation or review the FDA correction notice for information about this issue.
The recalled product
- Product
- The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 19,861
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 (3)
- UDI/DI 00085412610900
- Software Version v9.02.01
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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