Recall Z-2498-2025— Physio-Control, Inc.
Class II · Ongoing
Class II FDA medical device recall by Physio-Control, Inc., initiated 2025-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Due to required inspections not being performed on products/units that have gone through servicing..
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-22
- Firm location
- Redmond, WA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.