Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1499-2020 — HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.

U.S. FDA — Device Enforcement · United States · 2020-02-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1499-2020
Date of alert
2020-02-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America, LLC
Product category
device
Product type
Devices
Reported risk: Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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