Baxter Healthcare Recalls Infusion Software

Baxter Healthcare has recalled its Dose IQ Software Version 9.0.x, used with its Spectrum IQ Infusion Pumps.

The recall is due to a software defect that may improperly configure drug and fluid delivery. The FDA deems the recall Class I, the most serious type, because use of the faulty software may cause serious injuries or death.

The recall covers 61 copies of the software that were distributed between Feb. 1, 2018, and Jan. 1, 2019, along with all drug libraries initially created with version 9.0.x.

The FDA said it is aware of 15 complaints about the product, but that no injuries or deaths have been reported.