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

Recall Z-1633-2020 — LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (E

U.S. FDA — Device Enforcement · United States · 2020-03-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1633-2020
Date of alert: 2020-03-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Physio-Control, Inc.
Product category: device
Product type: Devices

Reported risk: Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment

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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