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

Recall Z-0683-2018 — Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option

U.S. FDA — Device Enforcement · United States · 2018-01-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0683-2018
Date of alert: 2018-01-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Electronics North America Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 989803139951

Reported risk: Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America

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.

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