Home / Recalls / Physio-Control, Inc. / Z-0817-2020

Z-0817-2020 Class II Terminated

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

FDA device recall Z-0817-2020 was initiated by Physio-Control, Inc. on December 20, 2019 and is designated Class II. Reason for recall: Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button. The recall status is terminated (terminated October 4, 2022). Affected quantity: 705.

Recall Details

Product Type
Devices
Report Date
January 22, 2020
Initiation Date
December 20, 2019
Termination Date
October 4, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
705

Product Description

LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits

Reason for Recall

Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.

Distribution Pattern

Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, Costa Rica, Canada, Singapore, Australia, France, Croatia, Italy , Sweden, Hungary,United Arab Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republic of the, Nigeria, Lao People's Democratic Republic, Russian Federation, Cyprus, Pakistan, Faroe Islands, Gabon,Libya, Thailand, Indonesia, Lithuania, Georgia, Malta, Macedonia, the former Yugoslav Republic of, Suriname, San Marino, Morocco, Guam, Taiwan, Province of China, Malaysia,Serbia, Brunei Darussalam, Argentina, Virgin Islands, U.S., Barbados, Mali, Iraq, Azerbaijan, Botswana, Kosovo, Cambodia, Cura¿ao, Ecuador, Aruba

Code Information

Serial numbers: 39432283 39432694 39432696 39432697 39432698 39432699 39432700 39432701 39432702 39432719 39432854 39432855 39432856 39432857 39432858 39432859 39432860 39432862 39432863 39432864 39432865 39432866 39432867 39432868 39432869 39432870 39432871 39432872 39432873 39432874 39432875 39432876 39432877 39432878 39432879 39432881 39432882 39432883 39432884 39432885 39432887 39432888 39432889 39432890 39432893 39432896 39432897 39432898 39432899 39432900 39432901 39435315 39436589 39451160 39451161 39451164 39451165 39451166 39451167 39451168 39451169 39451170 39451172 39451174 39451175 39451180 39451181 39451182 39451183 39451184 39451185 39451186 39451187 39451188 39451189 39451190 39451191 39451192 39451193 39451196 39451197 39451198 39451199 39451200 39451201 39451202 39451204 39451205 39451206 39451207 39451208 39451209 39451210 39451212 39451213 39451214 39451215 39451216 39451217 39451218 39451219 39451220 39451221 39451222 39451223 39451224 39451225 39451226 39451227 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Other recalls by Physio-Control, Inc.

  • Z-2065-2026 Class II — LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-0 (April 13, 2026)
  • 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-2497-2025 Class II — LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / (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-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-0230-2025 Class II — LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 9957 (August 30, 2024)
  • Z-0142-2025 Class II — STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEF (August 9, 2024)

FDA data resources