Alive ECG App 2.1.2 Recalled for Application Crashes
Alivecor is recalling Alive ECG App version 2.1.2 for iOS because the application crashes upon use.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software crash, a functional defect without reported injury.
Plain-English summary
Alivecor SFO is recalling Alive ECG App version 2.1.2, a medical device application for the Apple iOS operating system. The app is intended to be used with the AliveCor Heart Monitor to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The recall is due to the application crashing upon use.
Approximately 5,600 active users with the Alive ECG app for iOS are affected. The distribution pattern indicates the app was downloaded by Apple users, with specific locations not shared by Apple.
Consumers should stop using the affected version of the application. The source text does not provide specific instructions for remediation or alternative software versions.
The recalled product
- Product
- 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…
- Manufacturer
- Alivecor SFO
- Category
- Medical Device — Software
- Hazard
- Affected units
- 5,600
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)
- v2.1.2
Distribution
Distribution scope not specified by the agency.
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