Home / Recalls / Physio-Control, Inc. / Z-0230-2025

Z-0230-2025 Class II Ongoing

Recalled by Physio-Control, Inc. — Redmond, WA

Recall Details

Product Type
Devices
Report Date
November 6, 2024
Initiation Date
August 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
105 systems

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.

Distribution Pattern

U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A

Code Information

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

Other recalls by Physio-Control, Inc.

  • Z-1544-2026 Class II — PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Num (January 21, 2026)
  • Z-2498-2025 Class II — LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 (July 22, 2025)
  • Z-2499-2025 Class II — LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 88 (July 22, 2025)
  • Z-2497-2025 Class II — LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / (July 22, 2025)
  • Z-1232-2025 Class II — LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in c (February 3, 2025)
  • Z-1102-2025 Class II — LIFEPAK 35 ECG cable REF 11111-000041 (January 21, 2025)
  • Z-1184-2025 Class II — LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, a (January 21, 2025)
  • Z-0142-2025 Class II — STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEF (August 9, 2024)
  • Z-0567-2024 Class II — AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-0 (November 6, 2023)
  • Z-0296-2024 Class II — LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 (September 29, 2023)