PlainRecalls
FDA Devices Moderate Class II Ongoing

Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump

Reported: August 28, 2024 Initiated: July 17, 2024 #Z-2581-2024

Product Description

Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump

Reason for Recall

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 integrated with the hospital s EMR system.

Details

Units Affected
17,377 units
Distribution
US, Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump. Recalled by Baxter Healthcare Corporation. Units affected: 17,377 units.
Why was this product recalled?
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 integrated with the hospital s EMR system.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2581-2024.