FDA-Device2024-08-28Class II
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
Baxter Healthcare Corporation
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.
Sold states
US, Nationwide
Affected count
17,377 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2581-2024Don't want to check this manually?
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