FDADecember 6, 2017device

Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Inno...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.

What to do

FDA enforcement status: Terminated

Brands named

intel ge care innovationsintelintel ge

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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