Device 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.
Z-2497-2025
Product summary
- Event
- Event 96949
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2497-2025
Official wording
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Code information: Part / Catalog Numbers / UDI-DI code / Serial Number: V15-7-000022 / 99577-001957 / 883873871690 / 49085553 V15-2-000051 / 99577-000046 / 883873988022 / 38154524 V15-2-000099 / 99577-000093 / 883873979020 / 39059475 V15-2-001603 / 99577-001256 / 883873911631 / 40973093
Distribution pattern: U.S. Nationwide distribution in the states of CO and MT.
Derived failure modes
-
Unknown
Due to required inspections not being performed on products/units that have gone through servicing.