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

Recall Z-0204-2016 — Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A

U.S. FDA — Device Enforcement · United States · 2014-11-19 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0204-2016
Date of alert
2014-11-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
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.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.