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

Recall Z-2064-2020 — HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by trainin

U.S. FDA — Device Enforcement · United States · 2020-04-10 · 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-2064-2020
Date of alert: 2020-04-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips North America, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 453563478461

Reported risk: Damaged ESD bags used for storing components in Processor PCA Replacement Kits

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.

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.

Related