Aug

2024

FDA Recall: Spectrum WBM may fail to auto-document information to hospital’s EMR system

Company: Baxter Healthcare Corporation
Date of Enforcement Report: 8/16/2024
Class II

PRODUCT

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.

Recall Number:

Z-2581-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Baxter Healthcare Corporation

VOLUME OF PRODUCT IN COMMERCE:

17,377 units

DISTRIBUTION:

US, Nationwide

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Spectrum WBM may fail to auto-document information to hospital’s EMR system

Allison Pate

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