PlainRecalls
FDA Devices Moderate Class II Ongoing

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)

Reported: August 28, 2024 Initiated: July 17, 2024 #Z-2582-2024

Product Description

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)

Reason for Recall

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.

Details

Units Affected
17,377 units
Distribution
US, Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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). Recalled by Baxter Healthcare Corporation. Units affected: 17,377 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2582-2024.