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The U.S. Food and Drug Administration is aware that GE HealthCare has issued a letter to affected customers recommending all Portrait Mobile Monitoring Solutions operating on certain versions of Portrait Core Services software have updated use instructions.
GE HealthCare stated that during an update of Portrait Core Services software at a facility, some patients who were monitored on Portrait Mobile devices were discharged (removed) from the Portrait monitoring system.
In addition, all alarm settings may be reset to factory defaults following the updates. In this event, the device will not follow the alarm settings previously configured for each patient or care area.
This condition can result in a loss of patient monitoring or the intended alarms at the Hub and Central Viewer.
As of July 29, GE HealthCare has not reported any serious injuries or deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with questions about this recall should contact GE HealthCare at (800) 437-1171.
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