Spectrum With MDL
The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum…
The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum is designed for the application of standard gravity infusion sets as indicated by the Spectrums labeling.
5manufacturers in China registered for this device type
1catalogue number
52510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2022-10-19 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Special storage condition: Device Stored with Stand. Battery from -4 to 120 deg F (-20 to 49 deg C), Device Stored with WiFi Battery from -4 to 120 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35700BAX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251640 | 2025-07-28 |
| K251636 | 2025-07-28 |
| K242390 | 2024-09-05 |
| K211122 | 2024-03-29 |
| K230041 | 2023-03-31 |
| K230022 | 2023-03-31 |
| K222048 | 2022-09-06 |
| K211125 | 2022-08-30 |
| K220417 | 2022-04-29 |
| K173084 | 2018-05-11 |
| K133801 | 2014-05-07 |
| K070125 | 2007-04-16 |
| K052973 | 2007-01-25 |
| K040985 | 2004-11-30 |
| K041738 | 2004-07-09 |
| K041191 | 2004-06-25 |
| K010566 | 2001-05-15 |
| K003616 | 2000-12-12 |
| K002679 | 2000-09-18 |
| K002380 | 2000-09-05 |
| K002211 | 2000-07-28 |
| K993387 | 1999-11-01 |
| K961703 | 1996-07-08 |
| K953098 | 1995-12-22 |
| K945942 | 1995-07-10 |
| K940147 | 1994-04-15 |
| K923224 | 1994-02-24 |
| K915499 | 1992-03-06 |
| K915523 | 1992-02-28 |
| K915522 | 1992-02-28 |
| K913895 | 1991-10-21 |
| K905778 | 1991-07-12 |
| K910934 | 1991-06-24 |
| K910024 | 1991-05-31 |
| K911289 | 1991-05-21 |
| K910428 | 1991-04-08 |
| K910425 | 1991-04-01 |
| K910523 | 1991-03-21 |
| K903343 | 1990-11-21 |
| K900699 | 1990-04-10 |
| K891289 | 1990-02-02 |
| K884505 | 1989-07-14 |
| K884014 | 1988-12-12 |
| K880625 | 1988-04-19 |
| K873746 | 1988-01-06 |
| K852358 | 1985-07-05 |
| K830486 | 1983-04-14 |
| K821069 | 1982-06-10 |
| K813590 | 1982-01-28 |
| K813473 | 1982-01-22 |
| K782034 | 1979-02-27 |
| K761307 | 1977-01-06 |
Recalls Naming This Product
6 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 | 2025-06-20 | Class I | Employee error | Certain Spectrum infusion pumps may have an incorrect version of software. | 14 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. | 66 units | |
| Baxter Healthcare Corporation | UDI-DI | 2024-11-19 | Class II | Process control | Devices were identified as released after repair without full testing being performed, which includes flow testing. | 1 units | |
| Baxter Healthcare Corporation | UDI-DI | 2020-11-23 | Class II | Under Investigation by firm | There is a potential software error during programming. | 9,353 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. | 9352 units | 2024-04-29 |
| Baxter Healthcare Corporation | UDI-DI | 2020-06-30 | Class I | Labeling design | Baxter is updating the device IFU for safety communication regarding cleaning practices. | 310,969 units | 2024-04-29 |
Recalls
15 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-08-11 | Class II | Software design | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. | 14601 units | |
| 2026-08-11 | Class II | Software design | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains. | 4 units | |
| 2026-01-13 | Class II | Employee error | Pumps were released without full testing being performed, including occlusion alarm testing. | 5 | |
| 2025-11-28 | Class II | Nonconforming Material/Component | Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which coul | 585 units | |
| 2025-08-04 | Class I | Software design (manufacturing process) | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false m | 10,101 units | |
| 2025-08-04 | Class I | Software design (manufacturing process) | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false m | 22703 units | |
| 2025-08-04 | Class I | Software design (manufacturing process) | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false m | 43,922 units | |
| 2025-07-14 | Class I | Device Design | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or | 36705 units | |
| 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 | |
| 2025-05-12 | Class II | Device Design | Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps ‘user interface becomes stuck on the “Remove Syringe” screen when an infus | 8027 units | |
| 2025-04-24 | Class I | Device Design | There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the “standby mode” feature or if the device is powered off with the set loaded. | 34,524 units | |
| 2025-03-03 | Class II | Process control | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a res | 149 units | |
| 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 | |
| 2024-11-19 | Class II | Process control | Devices were identified as released after repair without full testing being performed, which includes flow testing. | 1 unit | |
| 2024-10-02 | Class II | Process control | The door on the Spectrum IQ Infusion pump may not be able to fully close. | 8 units | |
| 2024-07-17 | Class II | Under Investigation by firm | The Spectrum WBM may fail to auto-document infusion status information back to the hospital’s Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integra | 17,377 units | |
| 2024-07-17 | Class II | Under Investigation by firm | The Spectrum WBM may fail to auto-document infusion status information back to the hospital’s Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integra | 17,377 units | |
| 2024-06-14 | Class II | Under Investigation by firm | Improperly performed testing prior to release | 1 unit | |
| 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 | |
| 2024-03-20 | Class II | Nonconforming Material/Component | One device was improperly performed testing prior to release from a Service Center. | 1 pump | |
| 2023-10-13 | Class I | Under Investigation by firm | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in | 2023 units | |
| 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 | 3306 units | |
| 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 | |
| 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 | 146,502 units | |
| 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 | |
| 2021-07-07 | Class I | Software design | Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump. | 61 units | 2024-06-20 |
| 2021-06-04 | Class I | Software design | System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors. | 130135 units | 2024-09-25 |
| 2021-03-19 | Class II | Device Design | Potentially defective component in the AC power adapter which may fail over time. | 408 units | 2022-07-15 |
| 2021-01-06 | Class II | Under Investigation by firm | Battery performance issues related to prolonged storage. | 589,704 total units | 2026-05-04 |
| 2020-11-23 | Class II | Under Investigation by firm | There is a potential software error during programming. | 140,006 devices | |
| 2020-11-23 | Class II | Under Investigation by firm | There is a potential software error during programming. | 112,463 devices | |
| 2020-11-23 | Class II | Under Investigation by firm | There is a potential software error during programming. | 293,926 devices | |
| 2020-06-30 | Class I | Labeling design | Baxter is updating the device IFU for safety communication regarding cleaning practices. | 152,539 units | 2024-04-29 |
| 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 |
| 2018-06-21 | Class II | Process control | The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not iden | 158 | 2019-05-23 |
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.