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Recall Observatory FDA recall evidence

Device 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

Z-2581-2024

July 17, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94988
Status
Ongoing
Classification
Class II
Quantity
17,377 units
Official record key
device-enforcement:Z-2581-2024

Official wording

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.

Code information: Pump GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30

Distribution pattern: US, Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue