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FDA (Device enforcement)Recalled 2024-07-17class ii

Baxter Healthcare Corporation: 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

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.

Details from the source

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. Distribution: US, Nationwide Quantity: 17,377 units Lot/code info: Pump UDI/DI GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30

UPC codes

00085412498683

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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