Template: List of Known Anomalies

This template is intended to demonstrate the structure. Avoid using Microsoft Word—this is designed to be used as an Excel or Sheets document.

This list identifies technical issues (“bugs”) present in the current device that were deemed acceptable to remain unresolved prior to the release of the latest version.

It provides a comprehensive overview and documents the rationale for postponing corrections.

Regulatory References:

Standard Clause
IEC 62304:2006 Sections 5.7.5, 5.8.2 / 5.8.3

Anomalies

Title Description Impact / Risk Discovery (Date, Method, Reporter) Proposed Fix Reason for Postponement Timeline
Default language If the app is installed on a smartphone with an unsupported language, the default language is German. Users must navigate to the settings to change the language. Users in countries with unsupported languages are unlikely to speak German, potentially causing usability challenges until language settings change. 2022-04-01 during usability testing by Product Manager Change default language to English The app is currently restricted to regions where the supported languages match the predominant local languages. Next version release
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