FDA Devices recall · Reported February 25, 2015
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Alivecor Sfo recalled Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, in… - a low-severity action.
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, in… was recalled by Alivecor Sfo in February 25, 2015. Reason: Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the app…. Check the official notice for the remedy. Verify recall #Z-1125-2015 with the FDA Devices before acting.
The recall
Alivecor Sfo issued this low-severity FDA Devices recall-Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the app….
- Low
- severity level
- Class III
- classification
- February 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1125-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1125-2015) was formally reported on February 25, 2015, with the manufacturer initiating the action on January 9, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Alivecor Sfo is listed as the recalling firm, operating out of San Francisco, CA. Federal records list the affected scope as 5600 active users with Alive ECG app for iOS ..
The documented reason for this recall is: Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. Distribution data in the federal record shows the product reached: Downloaded by Apple users - locations not shared by Apple.. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
Reason for recall
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1125-2015 |
| Date reported | February 25, 2015 |
| Date initiated | January 9, 2015 |
| Recalling firm | Alivecor Sfo |
| Firm location | San Francisco, CA |
| Affected scope | 5600 active users with Alive ECG app for iOS . |
| Distribution | Downloaded by Apple users - locations not shared by Apple. |
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-1125-2015) 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.
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Methodology · Corrections · Archive as of August 2026