Intel-GE Care Innovations LLC: Medical Device Recall in 2018 - (Recall #: Z-2442-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 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. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.

Product Classification:

Class II

Date Initiated: December 6, 2017

Date Posted: July 25, 2018

Recall Number: Z-2442-2018

Event ID: 80382

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1302

Code Information:

Version v 2.5.2.29

Distribution Pattern:

US Nationwide Distribution in the states of CO, ID, PA, and LA

Voluntary or Mandated:

Voluntary: Firm initiated