Recall Z-2497-2025— 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 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.. 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 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
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.