FDA-Device2025-09-10Class II
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
Physio-Control, Inc.
Hazard
Due to required inspections not being performed on products/units that have gone through servicing.
Sold states
U.S. Nationwide distribution in the states of CO and MT.
Affected count
3 units
Manufactured in
11811 Willows Rd Ne, N/A, Redmond, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2025Don't want to check this manually?
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