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

HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical p — recall Z-0963-2015

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0963-2015
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: Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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.

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