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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 15 monitor/defibrillator

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  Class 2 Device Recall LIFEPAK 15 monitor/defibrillator see related information
Date Initiated by Firm December 20, 2019
Create Date January 16, 2020
Recall Status1 Open3, Classified
Recall Number Z-0817-2020
Recall Event ID 84425
510(K)Number K142430  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
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 39451228 39451229 39451230 39451232 39451233 39451234 39451235 39451236 39451237 39451238 39451239 39451240 39451241 39451242 39451247 39451248 39451249 39451250 39451251 39451253 39451254 39451255 39452420 39452421 39452422 39452423 39452424 39452431 39452432 39452433 39452434 39452435 39452436 39452437 39452438 39452439 39452440 39452441 39452442 39452444 39452445 39452446 39454151 39454152 39454153 39454154 39454155 39454156 39454157 39454158 39454160 39454161 39454162 39454163 39454164 39454165 39454166 39454167 39454168 39454169 39454171 39454172 39454173 39454174 39454175 39454176 39454177 39454178 39454179 39454180 39454181 39454182 39454183 39454184 39454185 39454186 39454187 39454188 39454189 39454190 39454191 39454192 39454193 39454194 39454195 39454196 39454197 39454198 39454199 39454200 39454201 39454202 39454203 39454204 39454205 39454206 39454207 39454208 39454209 39454210 39454212 39454213 39454223 39454224 39454225 39454226 39454232 39454233 39454234 39454235 39454236 39454237 39454238 39454240 39454242 39454243 39454245 39454247 39454249 39454250 39454252 39454254 39454256 39454258 39454259 39454262 39454263 39454265 39454267 39454269 39454271 39454274 39454275 39454276 39454277 39454278 39454279 39454280 39454281 39454282 39454283 39454284 39454286 39454292 39454293 39454345 39454346 39454347 39454348 39454349 39454350 39455249 39455254 39455260 39455261 39455262 39455263 39455264 39455265 39455266 39455267 39455268 39455269 39455270 39455271 39455272 39455273 39455274 39455275 39469498 39765227 39765228 39765229 39797896 39797897 39797898 39848745 39870587 39870588 39870589 39870590 39870591 39870592 39870593 39870594 39870595 39870596 39870597 39870598 39870599 39870600 39870601 39900149 39900150 39957820 39957821 39957822 39957823 39957824 39957825 39957826 39957827 39957828 39957829 39957830 39957831 39957832 39957833 39957834 39957835 39957836 39957837 39957838 39957839 39957840 39957841 39957842 39957843 39957844 39957845 39957846 39957847 39957848 39957849 39957850 39957851 39969767 39969768 39969769 39976435 39976436 39976437 39976438 39976439 39976440 39992176 40018366 40029412 40073183 40073184 40073185 40073186 40073187 40073188 40073189 40073190 40073191 40073192 40073193 40073194 40073195 40073196 40073197 40073198 40073199 40073200 40073201 40073202 40073203 40073204 40073205 40073206 40083271 40083272 40083273 40083274 40083275 40098253 40098284 40098285 40134736 40155264 40155265 40155266 40155267 40155268 40155270 40200460 40200461 40200462 40200463 40200464 40200465 40200466 40200467 40200468 40200469 40200470 40200471 40200472 40200473 40200474 40200475 40200476 40200477 40200478 40200479 40200480 40200481 40200482 40200483 40200484 40200485 40200486 40200487 40200488 40200489 40200490 40200491 40200492 40200493 40200494 40200495 40200496 40200497 40200498 40200499 40200500 40200501 40200502 40200503 40223041 40223108 40259482 40259483 40308355 40365560 40373398 40373399 40373400 40373401 40373402 40373403 40373404 40376119 40376120 40376121 40376122 40376123 40376124 40376126 40376127 40425282 40425284 40430207 40451516 40451517 40451518 40511094 40526038 40526039 40555692 40555693 40571561 40571562 40675678 40683854 40773964 40782038 40844317 40844318 40844319 40844320 40972282 40972283 40972284 40972285 40972286 40972287 41115933 41134276 41134277 41134278 41134279 41134280 41134281 41134282 41134305 41134306 41134307 41175436 41192414 41257757 41257854 41257855 41257856 41284206 41285699 41285700 41306258 41306259 41309457 41309458 41309459 41310408 41343876 41393000 41413082 41431719 41449087 41452842 41452843 41452844 41481191 41481192 41481237 41481238 41481239 41481240 41481241 41481242 41481243 41501719 41515010 41516183 41565053 41585332 41585333 41689156 41780036 41838344 41854433 41867210 42037067 42037068 42062355 42062356 42073127 42073128 42073129 42115550 42115551 42152720 42188494 42195206 42219112 42219113 42219114 42254374 42254375 42254376 42270320 42307547 42355805 42370263 42370264 42370265 42370266 42408704 42428589 42488221 42509883 42583674 42583675 42583676 42583677 42583678 42583679 42587304 42602630 42602663 42653129 42681417 42681418 42681419 42681420 42681421 42721321 42764328 42807318 42860374 42948200 42948201 42948953 42971721 42971722 42971723 42971724 43017692 43116701 43170932 43170934 43170935 43170936 43170937 43170938 43170939 43188697 43490106 43490107 43490108 43490109 43694866 43759250 43801175 43888171 43958086 44061077 44094406 44303490 44303491 44303492 44303493 44303494 44303495 44303496 44303497 44303498 44303499 44303500 44303501 44303502 44303503 44345628 44356014 44356049 44356058 44435908 44435924 44435968 44449908 44449911 44449914 44552700 44597328 44687091 44687092 44687093 44687094 44687095 44687096 44687097 44687098 44687099 44687100 44687101 44687102 44687103 44687104 44687105 44687127 44710078 44820961 44820966 44820981 44828208 44846188 44846206 44846208 44846212 44846216 44846235 44941001 44976604 45105241 45105242 45108374 45343203 45343204 45394575 45394576 45394577 45394578 45394579 45394580 45394581 45451099 45486918 45569386 45890246 45911738 45915123 45949539 45987459 46012148 46062899 46322720 46686701 46686702 47342354 47657609 47703826 47703829 47830584 47849207 48128161 48128162 48128164 48128165 48128166 48128167 48128168 48128169 48128170 48128171 48418982 
Recalling Firm/
Manufacturer
Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact
425-867-4000
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action On 12/20/19, Urgent Medical Device Safety Notice & Correction Action Required notifications were mailed to customers informing them to review the affected device list (www.strykeremergencycare.com/fa282response). Upon confirmation of device status, field service personnel will contact you to arrange for the correction of the device, which will include a replacement of the affected keypad. The devices subject to this correction are planned to be serviced by June 30, 2021. You may continue to use affected Monitors/Defibrillators according to the Operating Instructions until the correction can be completed. The other functions of the device are not affected by this issue. Routine testing of your device may detect this fault condition. If the device fails the daily check prior to use a "disarming" message will be displayed, and the service light will be illuminated. Contact Technical Support immediately to report the incident. If the issue occurs during patient use, a "disarming" message will be displayed, and the service light will illuminate. Immediately repeat your charge and shock cycle according to the Operating Instructions. If you receive the "disarming" message again, utilize hard paddles or a backup device. Remove the device from service and contact Technical Support immediately to report the incident. Each customer received an impacted device list listing affected serial numbers. Customers were asked to go to https://www.strykeremergencycare.com/productnotices to provide verification of the status of affected devices and to acknowledge the corrective action. If you have questions regarding the continued safe use of your products, please contact our Technical Support team at 1-800-787-9537, 8:00 A.M. to 6:00 P.M. (EST), and select option 2. Service providers were provided with instructions pertaining to the replacement of affected keypads. Service providers outside of the U.S. were provided with kit serial numbers and asked to identify the de
Quantity in Commerce 705
Distribution 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHYSIO-CONTROL, INC.
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