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

Recall Z-1923-2019 — Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

U.S. FDA — Device Enforcement · United States · 2019-06-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1923-2019
Date of alert
2019-06-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America, LLC
Product category
device
Product type
Devices
Reported risk: The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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