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Recall Observatory FDA recall evidence

Device product

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

Z-1232-2025

February 03, 2025

Class II

Product summary

Firm
Physio-Control, Inc.
Event
Event 96095
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1232-2025

Official wording

Reason: Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Code information: Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467

Distribution pattern: U.S.: WV O.U.S.: N/A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect keypad was incorrectly installed onto a defibrillator/monitor.