Spectrum IQ
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…
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.
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | PHC |
| Device type | Infusion Safety Management Software |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-05-31 |
| Record revised | 2025-12-02 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Special storage condition: Device stored with wireless battery at -10 to 49 degrees Celsius, 14 to 120 degrees Fahrenheit, and 10 to 90 percent rel |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3570009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ivenix Infusion System | Fresenius Kabi AB | 6 |
| BD Intelliport | Becton, Dickinson AND Company | 5 |
| PharmGuard | ICU Medical, Inc | 4 |
| LifeShield Infusion Safety Software Suite | ICU Medical, Inc | 3 |
| Dose IQ Safety Software | Baxter Healthcare Corporation | 3 |
| Alaris | CareFusion 303, Inc | 3 |
| ICU Medical MedNet | ICU Medical, Inc | 3 |
| LifeShield Infusion Safety Software Suite – LifeShield CDR | ICU Medical, Inc | 2 |
| Alaris™ Guardrails™ Editor Software Kit, Model 8961 | CareFusion 303, Inc | 2 |
| BD Alaris | CareFusion 303, Inc | 1 |
| BD Alaris™ System Manager 9601, Software | CareFusion 303, Inc | 1 |
| Vigilant Software Suite | Fresenius Kabi AB | 1 |
Showing 12 of 20. All products under Infusion Safety Management Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230665 | 2024-03-29 |
| K211124 | 2022-08-30 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2026-01-13 | Class II | Employee error | Pumps were released without full testing being performed, including occlusion alarm testing. | 5 | |
| Baxter Healthcare Corporation | UDI-DI | 2025-07-14 | Class II | Nonconforming Material/Component | 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 | 6 units | |
| Baxter Healthcare Corporation | UDI-DI | 2025-02-05 | Class I | Under Investigation by firm | There is the potential for missing motor mounting screws, which may have occurred during the servicing process. | 323 units | |
| Baxter Healthcare Corporation | UDI-DI | 2024-04-09 | Class II | Under Investigation by firm | There is a potential for cracks on the mount of the front panel of the device. | 9 units | |
| Baxter Healthcare Corporation | UDI-DI | 2024-03-20 | Class II | Nonconforming Material/Component | One device was improperly performed testing prior to release from a Service Center. | 1 pump | |
| Baxter Healthcare Corporation | UDI-DI | 2023-06-15 | Class I | Under Investigation by firm | 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 followin | 19861 units | |
| Baxter Healthcare Corporation | UDI-DI | 2021-12-29 | Class I | Device Design | 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 al | 241,304 units | |
| Baxter Healthcare Corporation | UDI-DI | 2020-11-23 | Class II | Under Investigation by firm | There is a potential software error during programming. | 112,463 devices | |
| Baxter Healthcare Corporation | UDI-DI | 2020-06-30 | Class I | Labeling design | Baxter is updating the device IFU for safety communication regarding cleaning practices. | 146,224 units | 2024-04-29 |
| Baxter Healthcare Corporation | UDI-DI | 2018-09-18 | Class II | Software design | 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 programm | 354 units | 2020-08-19 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-06-20 | Class I | Employee error | Certain Spectrum infusion pumps may have an incorrect version of software. | 14 units |
| 2025-06-20 | Class I | Employee error | Certain Spectrum infusion pumps may have an incorrect version of software. | 28 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.