Spacelabs Recalls Arkon Anesthesia Delivery System With Version 2.0 Software

Snoqualmie, Wash., devicemaker Spacelabs Healthcare sent an Urgent Medical Device Correction letter to customers March 11, warning of a defect in the version 2.0 software accompanying its Arkon anesthesia delivery system.

The software defect may cause the system to shut down, prompting manual ventilation of patients in the operating room, according to the notice posted to the FDA’s website Thursday.

Spacelabs is contacting customers to schedule a free software update that will fix the problem, Until then, customers should not save spirometry loops or use the device’s USB ports, the company said. If the error occurs, customers should switch to emergency oxygen and manual ventilation or cycle power to reboot the system and continue mechanical ventilation.

The voluntary Class I recall affects 16 units of the device that were distributed to hospitals in North and South Carolina between March 18 and June 17, 2013. The company has received one adverse event report, but no reports of injuries or deaths.

View the recall notice at http://www.fdanews.com/ext/resources/files/04/04-18-14-SpacelabsRecall.pdf. —Lena Freund

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