U.K. Device Alerts In Brief
This article was originally published in The Gray Sheet
Executive Summary
GE Healthcare pulse oximeters: Firm's TruSat pulse oximeters could leak excessive electrical current, causing abnormal heart rhythms and third-degree burns, the U.K.'s Medicines and Healthcare products Regulatory Agency warns in a June 29 device alert. The pulse oximeter with external power supply "does not comply with current safety standards," explains a June 2 field safety notice. The warning also applies to TruSat pulse oximeters sold under the Datex-Ohmeda brand name. GE will replace all affected external power supplies with a new power supply