Cardiac Science issued an urgent field safety notice to announce a voluntary recall of its G3 Elite automated external defibrillator (AED) devices.
The Deerfield, Wis.-based company said in the notice that it received field reports saying that its G3 Elite devices’ “rescue ready” status indicator displayed red and the service LED was illuminated.
After investigating the issue, Cardiac Science traced the problem to a software anomaly associated with the Daylight Savings Time (DST) settings on the devices. If the device is configured with DST enabled, it will experience an error code that reads “0x99” after Daylight Savings.
Should the device reach this state, Cardiac Science said it must be returned to the company so it can clear the error, although it can be used clinically if an emergency arises. Cardiac Science also said that it is revising the software and will provide an update that is free of charge so the anomaly no longer occurs, but customers must return affected units so they may be updated.
FILED UNDER: CARDIOVASCULAR, RECALLS, REGULATORY/COMPLIANCE
TAGGED WITH: CARDIAC SCIENCE
