Spectrum IQ 3570009Recalls & reported problems
Baxter Healthcare Corporation · The Spectrum IQ Infusion System with Dose IQ Safety Software is an infusion pump that provides delivery of fluids into a patient in a controlled manner. The pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The Spectrum IQ infusion pump is specifically manufactured and calibrated for use with Baxter administration sets. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
9 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Baxter Spectrum IQ infusion pump appears in 8,979 adverse event reports, including 11 deaths and 187 injuries. The reports mostly describe false alarms, filling problems, and alarms or audible prompts that fail to sound. Of its 11 recalls, 9 are open and the other two are closed; the 9 open recalls cover missing screws, doors that may not close fully, and false occlusion alarms after software updates.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 9,086
- Deaths reported
- 10
- Injuries reported
- 187
- Recalls naming it
- 11
Summary
The FDA's MAUDE database contains 9,086 adverse event reports that list this exact device (DI 00085412610900), received between Oct 3, 2018 and Sep 30, 2026 — classified as 10 deaths, 187 injuries, 8,889 malfunctions.
The most frequently reported specific device problem is “False Alarm” (1,983 reports).
11 FDA recall records name this device's identifier, 9 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jan 13, 2026Class IIOpen, Classified
Pumps were released without full testing being performed, including occlusion alarm testing.
Z-1368-2026 · Root cause: Employee error · Recall details · FDA record ↗
- Jul 14, 2025Class IIOpen, Classified
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Z-2415-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Feb 5, 2025Class IOpen, Classified
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Z-1254-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 2, 2024Class IIOpen, Classified
The door on the Spectrum IQ Infusion pump may not be able to fully close.
Z-0348-2025 · Root cause: Process control · Recall details · FDA record ↗
- Apr 9, 2024Class IIOpen, Classified
There is a potential for cracks on the mount of the front panel of the device.
Z-1810-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 20, 2024Class IIOpen, Classified
One device was improperly performed testing prior to release from a Service Center.
Z-1775-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jun 15, 2023Class IOpen, Classified
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
Z-2104-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 29, 2021Class IOpen, Classified
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
Z-0529-2022 · Root cause: Device Design · Recall details · FDA record ↗
- Nov 23, 2020Class IIOpen, Classified
There is a potential software error during programming.
Z-0715-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 30, 2020Class ITerminated
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Z-0123-2021 · Root cause: Labeling design · Recall details · FDA record ↗
- Sep 18, 2018Class IITerminated
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
Z-0107-2019 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- False Alarm1,983
- Filling Problem1,810
- Failure to Sense1,693
- Inaudible or Unclear Audible Prompt/Feedback798
- No Audible Prompt/Feedback516
- No Display/Image480
- Defective Alarm383
- Protective Measures Problem295
Patient problems
- No Clinical Signs, Symptoms or Conditions7,951
- No Consequences Or Impact To Patient573
- No Patient Involvement353
- Low Blood Pressure/ Hypotension75
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available43
- High Blood Pressure/ Hypertension33
- Insufficient Information10
- Tachycardia9
Recent adverse event reports
The 25 most recent of 9,086 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951730 ↗MalfunctionSep 30, 2026Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951384 ↗MalfunctionSep 30, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950931 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950482 ↗MalfunctionSep 30, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949664 ↗MalfunctionSep 30, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949663 ↗MalfunctionSep 30, 2026False Alarm
It was reported that a Spectrum IQ Infusion Pump alarmed upstream occlusion during preventive maintenance. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949339 ↗MalfunctionSep 30, 2026Defective Alarm
It was reported that a Spectrum IQ Infusion Pump failed downstream occlusion test during preventive maintenance. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948947 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941447 ↗MalfunctionSep 29, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937957 ↗MalfunctionSep 29, 2026Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935609 ↗MalfunctionSep 29, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926720 ↗MalfunctionSep 28, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926364 ↗MalfunctionSep 28, 2026Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926123 ↗MalfunctionSep 28, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925467 ↗MalfunctionSep 28, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923438 ↗MalfunctionSep 28, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923307 ↗MalfunctionSep 28, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923306 ↗MalfunctionSep 28, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923187 ↗MalfunctionSep 28, 2026Filling Problem
It was reported that a Spectrum IQ Infusion Pump had low flow rate (under infusion) during programming/setup. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920883 ↗MalfunctionSep 25, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904641 ↗MalfunctionSep 25, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904493 ↗MalfunctionSep 25, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902548 ↗MalfunctionSep 25, 2026Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion
It was reported that a Spectrum IQ Infusion Pump inaccurately delivered Parenteral Nutrition (PN), with an excessive amount remaining in the bag at the end of the infusion. The pump was reported to infuse PN (Parenteral Nutrition) 5-10% faster or slower than expected over extended periods during patient infusion. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899800 ↗MalfunctionSep 25, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899126 ↗
Other Infusion safety management software devices
- SIGMA Spectrum Infusion Pump 35700BAX2Baxter Healthcare Corporation · Infusion safety management software9 recalls12 deaths11,585 reports
- Alaris 8975Carefusion 303, Inc. · Infusion safety management software169 reports
- LifeShield Infusion Safety Software Suite 17003-02ICU Medical, Inc. · Infusion safety management software2 recalls0 reports
- Alaris 9601Carefusion 303, Inc. · Infusion safety management software2 recalls0 reports
- BD Alaris™ Infusion Adapter, Software Not ApplicableCarefusion 303, Inc. · Infusion safety management software1 recall0 reports
- LifeShield Infusion Safety Software Suite - LifeShield DLM 2.1Icu Medical, Inc. · Infusion safety management software1 recall0 reports
- BD Intelliport 516704Becton, Dickinson And Company · Infusion safety management software28 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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