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Terminated

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

Recall StatusTerminated
Product CodeMKJ
Date Initiated2020-04-27
Date Terminated2021-07-19
Product Quantity260 units

Reason for Recall

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

Firm Action

Philips Issued Urgent Medical Device Removal Letter (FSN86100214) on 4/27/20 via Certified Mail to U.S. customers, via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk, action to take: Upon receipt of this notification, promptly locate the affected MRx M3535A, M3536A, and M3536M devices remove them from clinical use immediately. A Philips representative will contact you to arrange removal of the affected devices for evaluation. If you need further information or support concerning this notification. please contact your local Philips representative or call us at 1 -800-722-9377.

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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