PlainRecalls
FDA Devices Moderate Class II Ongoing

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm

Reported: September 10, 2025 Initiated: July 22, 2025 #Z-2498-2025

Product Description

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Reason for Recall

Due to required inspections not being performed on products/units that have gone through servicing.

Details

Recalling Firm
Physio-Control, Inc.
Units Affected
3 units
Distribution
U.S. Nationwide distribution in the states of CO and MT.
Location
Redmond, WA

Frequently Asked Questions

What product was recalled? ▼
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.. Recalled by Physio-Control, Inc.. Units affected: 3 units.
Why was this product recalled? ▼
Due to required inspections not being performed on products/units that have gone through servicing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2498-2025.

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