Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
FDA Recall Z-2157-2020 · Posted None
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Reason for Recall
Firm Action
Root Cause
Process change control
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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