2011 February 11.

MASIMO ADVISORY NOTICE
Inability to retain user default settings on Rad 8 device after power cycle.

Reason for Advisory Notice:
Rad-8 device has been noted to revert back to factory default settings after power cycle.  Device functions as intended once user setting are configured or verified after power cycle, there is no impact to performance.

View Advisory Notice

2010 March 18.

URGENT MEDICAL DEVICE CORRECTION
Potential risk when using GE Healthcare Pulse Oximeter with External Power Supply

GE Healthcare has recently become aware that the TruSat Pulse Oximeter with external power supply does not comply with current safety standards.  It is possible that the external power supply could leak electrical current.  This current could cause third degree burns or an abnormal heart rhythm that, if untreated, could lead to death.

more...