Stryker has identified an issue with the LP35 where the device does not display the message "CHECK RHYTHM / ECG Analysis Inconclusive" as intended when specific conditions are present simultaneously. The issue does not affect the display of "shock advised" or "no shock advised" messages, and therapy delivery remains available. Additionally, this nonconformance is limited to the device on-screen prompts only; rhythm analysis is not impacted by this issue.
法规动态2026年9月2日•1 分钟阅读
Stryker LP35 Defibrillator Display Issue Identified
Stryker reports the LP35 may not display the "CHECK RHYTHM / ECG Analysis Inconclusive" message under certain conditions, while shock advisories and therapy remain functional.
由 PharmaCountry 团队整理 · 来源： Health Canada
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