FDAFDA · Food and drugs·Recall number Z-0230-2025
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.
Published November 6, 2024 · Recall initiated: August 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to an out of tolerance tool being used on monitor/defibrillator systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Physio-Control, Inc.
- Distributor
- U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
- Lot
- 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 UDI-DI codes: o 00883873808214 o 00883873988022 o 00883873979426 o 00883873979358 o 00883873911693 o 00883873979198 o 00883873911648 o 00883873884386 o 00883873871713 o 00883873871706 o 00883873871690 o 00883873871683 o 00883873911631 o 00883873871645 Serial Numbers: o 45435833 o 46470647 o 46686048 o 46686573 o 46686708 o 46687360 o 46906073 o 49037777 o 49704552 o 38166647 o 38282988 o 38290136 o 38291331 o 38802782 o 39541663 o 39541666 o 39752193 o 40259639 o 41446867 o 41447020 o 41453331 o 42325059 o 43574409 o 43984215 o 45040678 o 45308104 o 45455023 o 46017745 o 46572054 o 46576300 o 48349664 o 48605645 o 48605663 o 49001744 o 49025185 o 49070762 o 49087040 o 49087053 o 49224619 o 49374174 o 49422314 o 49619921 o 38200440 o 38805564 o 38805583 o 39382735 o 41446693 o 41446882 o 41446975 o 41446977 o 41447027 o 41453239 o 41893891 o 42324176 o 42610924 o 43181935 o 43182268 o 43182389 o 43462227 o 43465372 o 43487806 o 43610792 o 43791346 o 43841374 o 43860850 o 43862247 o 43869747 o 44169862 o 44356379 o 44360003 o 44601246 o 45590467 o 45907317 o 46364496 o 46691551 o 47447195 o 47515791 o 47539203 o 47539310 o 47785570 o 47794250 o 48524850 o 48583111 o 48585709 o 48600317 o 48605407 o 48605467 o 48704914 o 48749443 o 49022830 o 49031342 o 49036187 o 49056308 o 49057928 o 49123367 o 49126651 o 49127012 o 49132399 o 49132740 o 49134638 o 49511402 o 49513814
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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