Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump V8

Certain Spectrum infusion pumps may have an incorrect version of software.

Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

An URGENT MEDICAL DEVICE RECALL notification letter dated 6/20/25 was sent to customers. Actions to be Taken by Customers 1. Immediately locate Spectrum pumps with the affected serial numbers and remove them from service. The product code and serial number can be found on the bottom of the infusion pump. 2. Check and record the software version installed on the pump. The software on a V6 pump should begin with the number 6 and the software on a V8 pump should begin with the number 8. The software version is located on the startup screen upon powering up the pump as pictured on the next page. Additionally, the software version is indicated in the pump menu which can be accessed by following the steps. For V6: From the Pump Information screen, press the sw info soft key to display the software version screen. For V8: From the Select Care Area screen, press the options menu soft key. Select User Options and press OK. Select View Information and press OK. Select Pump Information and press OK to display the Pump Info screen. 3. Contact Baxter to confirm the software version on the affected pumps and to schedule service if required. Baxter Global Technical Services can be reached at 800-843-7867 (select option 1, then option 2), Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. 4. If you received this communication directly from Baxter, acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 5. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them

• FDA enforcement recordOfficial FDA database entry for Z-2096-2025
• FDA 510(k) clearance · K230022The device's official FDA premarket clearance record
• FDA device classification · PHCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.