FDA-Device2024-08-28Class II
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ 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
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2582-2024Don't want to check this manually?
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