Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 25, 2018
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) fro
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 bac…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Intel-GE Care Innovations LLC recalled Health Harmony Mobile application software Product Usage: Care Innovations Health Ha… - a moderate-severity action.
Health Harmony Mobile application software Product Usage: Care Innovations Health Ha… was recalled by Intel-GE Care Innovations LLC in July 25, 2018. Reason: It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, …. Check the official notice for the remedy. Verify recall #Z-2442-2018 with the FDA Devices before acting.
The recall
Intel-GE Care Innovations LLC issued this moderate-severity FDA Devices recall-It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, ….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- July 25, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2442-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2442-2018) was formally reported on July 25, 2018, with the manufacturer initiating the action on December 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Intel-GE Care Innovations LLC is listed as the recalling firm, operating out of Roseville, CA. Federal records list the affected scope as 1302.
The documented reason for this recall is: 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'… Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of CO, ID, PA, and LA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1302
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2442-2018 |
| Date reported | July 25, 2018 |
| Date initiated | December 6, 2017 |
| Recalling firm | Intel-GE Care Innovations LLC |
| Firm location | Roseville, CA |
| Affected scope | 1302 |
| Distribution | US Nationwide Distribution in the states of CO, ID, PA, and LA |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2442-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Intel-GE Care Innovations LLC. Units affected: 1302.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2442-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of CO, ID, PA, and LA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2442-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.