Events

Recall of Device Recall Powerheart 9390E automated external defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55603
  • Event Risk Class
    Class 2
  • Event Number
    Z-1810-2010
  • Event Initiated Date
    2009-12-18
  • Event Date Posted
    2010-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91319
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    The k302 relay switch of the g3 series aed product line may experience an early failure. if the k302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy.
  • Action
    Customer notification letters were mailed to US end users and distributors (final consignees) between December 18 and 23, 2009 by USPS certified mail, return receipt requested. Notification letters were sent by FedEx to Canadian distributors (final consignees) on December 23, 2009. Secondary consignee (distributor) letters were mailed on December 23, 2009. Letters advise user to check the status indicator on front of AED to determine if it is rescue ready. Users are advised to keep the AED in service and to perform the Daily and Monthly Scheduled Maintenance as outlined in the Operator and Service Manual. Questions about this communication should be addressed to 1.877.901.1788 toll free from inside the US, or to email .

Device

Device Recall Powerheart 9390E automated external defibrillator
  • Model / Serial
    Serial Numbers: 4259985, 4260065, 4260137, 4260148, 4260174, 4260179, 4260181, 4261110, 4261111, 4261112, 4261113, 4261114, 4261115, 4261116, 4261117, 4261118, 4261119, 4261120, 4261121, 4261122, 4261123, 4261125, 4261126, 4261127, 4261128, 4261129, 4261130, 4261131, 4261132, 4261133, 4261134, 4261136, 4261138, 4261139, 4261140, 4261141, 4261142, 4261143, 4261144, 4261145, 4261147, 4261149, 4261150, 4261151, 4261153, 4261154, 4261155, 4261156, 4261157, 4261158, 4261160, 4261161, 4261162, 4261163, 4261164, 4261166, 4261168, 4261169, 4261170, 4261172, 4261174, 4261175, 4261177, 4261178, 4261179, 4261180, 4261181, 4261182, 4261183, 4261184, 4261185, 4261186, 4261188, 4261189, 4261190, 4261216, 4261217, 4261284, 4261285, 4261292, 4261299, 4261300, 4261301, 4261305, 4261306, 4261308, 4261312, 4261313, 4261317, 4261319, 4261320, 4261321, 4261325, 4261326, 4261329, 4261330, 4261332, 4261333, 4261342, 4261343, 4261348, 4261351, 4261352, 4261355, 4261356, 4261358, 4261360, 4261361, 4261365, 4261370, 4261381, 4261382, 4261383, 4261384, 4261385, 4261386, 4261387, 4261388, 4261394, 4261395, 4261396, 4261397, 4261398, 4261399, 4261400, 4261401, 4261402, 4261403, 4261404, 4261405, 4261406, 4261407, 4261408, 4261409, 4261410, 4261411, 4261412, 4261413, 4261414, 4261415, 4261416, 4261417, 4261420, 4261422, 4261423, 4261425, 4261449, 4261450, 4261451, 4261463, 4261465, 4261473, 4261475, 4261476, 4261477, 4261478, 4261479, 4261480, 4261481, 4261482, 4261483, 4261484, 4261485, 4261486, 4261487, 4261488, 4261489, 4261490, 4261492, 4261495, 4261496, 4261498, 4261499, 4261500, 4261501, 4261502, 4261503, 4261505, 4261506, 4261507, 4261508, 4261512, 4261513, 4261514, 4261515, 4261516, 4261517, 4261518, 4261519, 4261520, 4261522, 4261523, 4261524, 4261526, 4261527, 4261528, 4261529, 4261530, 4261531, 4261532, 4261534, 4261535, 4261536, 4261537, 4261538, 4261539, 4261540, 4261541, 4261542, 4261543, 4261544, 4261545, 4261546, 4261547, 4261548, 4261549, 4261551, 4261552, 4261554, 4261555, 4261557, 4261558, 4261559, 4261560, 4261561, 4261562, 4261563, 4261564, 4261565, 4261566, 4261567, 4261568, 4261570, 4261571, 4261572, 4261573, 4261574, 4261575, 4261576, 4261577, 4261579, 4261580, 4261586, 4261587, 4261592, 4261597, 4261598, 4261605, 4261608, 4261610, 4261611, 4261613, 4261614, 4261615, 4261617, 4261618, 4261621, 4261623, 4261624, 4261626, 4261628, 4261630, 4261631, 4261632, 4261633, 4261634, 4261635, 4261636, 4261637, 4261638, 4261639, 4261640, 4261641, 4261642, 4261643, 4261644, 4261645, 4261646, 4261647, 4261648, 4261649, 4261650, 4261651, 4261652, 4261653, 4261654, 4261656, 4261657, 4261660, 4261662, 4261663, 4261664, 4261665, 4261666, 4261670, 4261672, 4261676, 4261678, 4261679, 4261680, 4261683, 4261688, 4261689, 4261690, 4261691, 4261692, 4261695, 4261696, 4261697, 4261700, 4261709, 4261711, 4261712, 4261713, 4261714, 4261716, 4261718, 4261721, 4261726, 4261727, 4261729, 4261733, 4261734, 4261737, 4261739, 4261744, 4261745, 4261746, 4261747, 4261748, 4261750, AND 4261751.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Domestic: 323 units to distributors and end users. Canada: 9 units to 2 distributors.
  • Product Description
    Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Manufacturer Address
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Manufacturer Parent Company (2017)
    Cardiac Science Corporation
  • Source
    USFDA