Class 2 Device Recall Health Harmony Mobile

• Date Initiated by Firm: December 06, 2017
• Create Date: July 16, 2018
• Recall Status: Terminated on October 23, 2020
• Recall Number: Z-2442-2018
• Recall Event ID: 80382
• Product Classification: Medical device data system - Product Code OUG
• Product: 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.
• Code Information: Version v 2.5.2.29
• FEI Number: 3008850109
• Recalling Firm/ Manufacturer: Intel-GE Care Innovations LLC; 3721 Douglas Blvd Ste 100; Roseville CA 95661-4243
• For Additional Information Contact: Marcus Grindstaff; 800-450-0970
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm sent e-mails to their 4 consignees during the first week of December 2017. with the following information: As you may know, we have discovered a technical issue in our Health Harmony product that may result in some patient data not being transmitted to the Maestro 2 clinical dashboard in a timely manner (i.e. vital signs, health session answers). This can also manifest as a patient unable to execute their health session. Our investigation shows that in some cases, your clinical team may not receive patient readings in the normal timeframe. We take this issue very seriously. We are focused on investigating the root cause while also mitigating the effects on patient management as our engineering team solves the issue. While we continue to investigate this issue, we are developing a mitigation and will begin deploying shortly. This includes a progress notice and a message on the patient tablet when the system is synchronizing and transmitting results. The message will remind patients to stay in the program until their results have successfully uploaded and transmitted. Please be assured we are urgently working on addressing this issue. Your Care Innovations program management team will follow up with you to discuss potential impact on your standard of care, the next steps and answer any questions you may have about this situation. Thank you for your continued patience, Marcus Grindstaff CHIEF OPERATING OFFICER Care Innovations Cell: 916.548.3013
• Quantity in Commerce: 1302
• Distribution: US Nationwide Distribution in the states of CO, ID, PA, and LA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.