FDAnews
www.fdanews.com/articles/137367-risk-of-electric-shock-burns-prompts-medical-device-alert-for-ge-8217-s-pulse-oximeter

Risk of Electric Shock, Burns Prompts Medical Device Alert for GE’s Pulse Oximeter

June 6, 2011
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for GE’s TruSat pulse oximeter due to power supply issues. The plastic cases of the external power supply may break, exposing live parts, or may overheat and deform, presenting a risk of electric shock or burns to users.