FDAJuly 17, 2024device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
UPCs
00085412498683
Recall history
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