SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 recallZ-2103-2023 · Baxter Healthcare Corporation · initiated Jun 15, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Customers were contacted via phone and email beginning on June 2, 2023. An Urgent Medical Device communication was sent to all affected customers on June 15, 2023, via U.S.P.S., first class mail. The notice explained the problem, the risk involved, and requested the following: "Actions to be taken by Customers: 1. Operators may continue to use Spectrum V8 and Spectrum IQ pumps by following on-screen instructions, or the infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the Operator s Manual. An electronic copy of the Operator s Manual can be accessed at https://service.baxter.com/tsportal/. Please note that false upstream occlusion alarms can occur at a higher rate until the software reversion is completed. If you are unable to resolve an upstream occlusion alarm, unload and reload the set. 2. A Baxter representative will contact your facility to determine the correction plan and schedule the software reversion. The representative will work with you to determine a list of affected serial numbers at your facility. Please note you will be receiving this software reversion from Baxter at no charge." "Further information and support: If you have additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-356-3454 (choose option 3) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."

Recall details

Recall number: Z-2103-2023
Status: Open, Classified
Initiated by the company: Jun 15, 2023
Posted by the FDA: Jul 13, 2023
Recalling firm: Baxter Healthcare Corporation
Quantity: 3306 units
Product code: FRN
FDA submissions: K230022
Distribution: US Nationwide distribution.

Product description

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

Code information (models, lots, serial numbers)

GTIN 00085412498683, Software version v8.01.01, Serial Numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

SIGMA Spectrum Infusion Pump 35700BAX2
Baxter Healthcare Corporation · Infusion safety management software
9 recalls12 deaths11,585 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92562).

Z-2104-2023 · Open, Classified
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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