RecallRadar

FDA Device recall Z-1232-2025

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

On 2025-03-05 the FDA classified a Class II recall of LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest by Physio Control, citing incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1232-2025
ClassificationClass II
Statusongoing
Initiated2025-02-03
Published2025-03-05
Last updated2026-09-13 11:57 UTC
CompanyPhysio Control
DistributionWV

Product

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

Reason

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Identifiers

code_infoModel/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1232-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.