Recall Z-0230-2025— Physio-Control, Inc.
Class II · Ongoing
Class II FDA medical device recall by Physio-Control, Inc., initiated 2024-08-30. FDA's recall record names no specific 510(k) clearance for this event. Product: LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.. Reason: Due to an out of tolerance tool being used on monitor/defibrillator systems..
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-30
- Firm location
- Redmond, WA, United States
Product description
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
Reason for recall
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Data sourced from openFDA. This site is unofficial and independent of the FDA.