Health Harmony Mobile App Recalled for Data Synchronization Delays
Intel-GE Care Innovations LLC is recalling the Health Harmony Mobile application because patient data sometimes failed to sync with the backend database in a timely manner.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in data synchronization (one to two days) without reported injuries or illnesses, fitting the criteria for a moderate severity issue involving a medical device software defect.
Plain-English summary
Intel-GE Care Innovations LLC is recalling 1,302 units of the Health Harmony Mobile application software, version v 2.5.2.29. This software is intended as a communication tool to display medical device data from third-party devices for patients to view and to collect assessment questions and answers from patients in the home.
The recall was initiated because it was discovered that in certain situations, including partial sessions and when taking ad hoc measurements, patient data was not synchronizing in a timely manner with the backend database. This delay resulted in the patient's clinician not receiving patient data for one or two days.
The affected units were distributed nationwide in the states of Colorado, Idaho, Pennsylvania, and Louisiana. The source text does not specify further instructions for consumers or patients regarding this recall.
The recalled product
- 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…
- Manufacturer
- Intel-GE Care Innovations LLC
- Affected units
- 1,302
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version v 2.5.2.29
Distribution
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