Devices

Device Recall LIFEPAK 12 Defibrillator/Monitor

  • Model / Serial
    LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544.  SERIAL NUMBERS OF DEVICES:  32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
  • Product Description
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. || The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). || The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
  • Manufacturer
    Physio-Control, Inc.
  • 1 Event

Manufacturer

Physio-Control, Inc.
  • Manufacturer Address
    Physio-Control, Inc., 11811 Willows Rd NE, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Model / Serial
    Part Number: LP12, VLP12-02-(various dash numbers).  Serial Numbers (non-contiguous): 8529728, 8529728, 9210418, 9210419, 9599334, 10128750, 10132851, 10248200, 10389064, 11120818, 11244332, 11252979, 11252980, 11252981, 11289300, 11311777, 11311778, 11311782, 11311787, 11316922, 11372139, 11424301, 11424819, 11471546, 11568711, 11610477, 11766215, 11766216, 11766222, 11767531, 11767565, 11877154, 12007118, 12007124, 12007129, 12007131, 12007135, 12009524, 12009528, 12030152, 12209828, 12209830, 12209832, 12209834, 12551932, 12551934, 12551936, 12551937, 12551939, 12776733, 12776734, 12779439, 12779439, 12789243, 13165363, 13269232, 13423039, 13434816, 13434837, 13522303, 13536842, 13704769, 13704770, 13870608, 13993048, 14008074, 14008075, 14201185, 14201186, 14201187, 30646561, 32117838, 32117838, 32117839, 32117839, 32117840, 32117840, 37125611, 37125612, 37125617, 37125743, 37125751, 37125752, 37125753, 37126327, 37126328, 37126329, 37126330, 37126331, 37126332, 37126333, 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37628552, 37628553, 37628554, 37628555, 37628556, 37628557, 37628558, 37628559, 37628560, 37628561, 37628562, 37628563, 37628564, 37628565, 37628566, 37628567, 37628568, 37628569, 37628570, 37628571, 37628572, 37628573, 37628574, 37628575, 37628576, 37628577, 37628578, 37628579, 37628580, 37628581, 37628582, 37628583, 37628584, 37628585, 37628586, 37628587, 37628588, 37628589, 37628590, 37628591, 37628592, 37628593, 37628594, 37628595, 37628596, 37628597, 37628598, 37628599, 37628600, 37628601, 37628602, 37628603, 37628604, 37628605, 37628606, 37628607, 37628608, 37628609, 37628610, 37628611, 37628612, 37628613, 37632499, 37632500, 37632501, 37632502, 37632503, 37632504, 37632918, 37632922, 37632941, 37632945, 37632946, 37632947, 37632948, 37632951, 37632952, 37632953, 37632955, 37632956, 37632958, 37632959, 37632960, 37632961, 37632963, 37632964, 37632967, 37633634, 37633636, 37636570, 37636571, 37636572, 37636573, 37636574, 37636575, 37636576, 37636577, 37636578, 37636579, 37636659, 37652880, 37652883, 37652883, 37660898, 37660902, and 37661630.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.
  • Product Description
    Biphasic LIFEPAK 12 defibrillator / monitor.
  • Manufacturer
    Physio Control, Inc.
Device Recall LIFEPAK 12 Defibrillator/MonitorAC Power Adapter
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.Devices were distributed to the following countries: ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.
  • Product Description
    The LIFEPAK12 Defibrillator/Monitor. || The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected.
  • Manufacturer
    Physio Control, Inc.