Software Glitch Triggers Class I Recall of Hospira Symbiq Infusion Pumps

Hospira is voluntarily recalling an infusion pump due to reports the device’s touch screen control panel may become unresponsive, according to a recent FDA bulletin.

The nationwide Class I recall, announced Oct. 29, involves one- and two-channel versions of the Hospira Symbiq Infusion System from all distribution dates.

Lake Forest, Ill.-based Hospira first informed customers of the recall in an Aug. 29 letter. While not requesting that the units be returned at the time, the letter advised operators to consult the instruction manual and double-check the dosage on the touchscreen before beginning therapy.

Simple manufacturing mishaps can lead to recalls costing devicemakers thousands of dollars. Regulatory agencies around the world could change what manufactures must do when a recall is performed, but FDAnews’ Devices & Diagnostics Letterwill keep you informed on any change or guidance these agencies might offer.

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