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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart defibrillator

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 Class 2 Device Recall HeartStart defibrillator see related information
Date Posted July 09, 2008
Recall Status1 Terminated on October 23, 2012
Recall Number Z-1779-2008
Recall Event ID 47833
510(K)Number K020715  K040904 
Product Classification Defibrillator - Product Code MKJ
Product Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Philips "HeartStart On Site Defibrillator" and outside the U.S. by Philips with the brand name Philips "HeartStart Defibrillator". The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
Code Information 5 A05I-01106 A05I-01107 A05I-01108 A05I-01109 A05I-01110 A05I-01111 A05I-01112 A05I-01113 A05I-01115 A05I-01116 A05I-01117 A05I-01118 A05I-01119 A05I-01120 A05I-01122 A05I-01123 A05I-01124 A05I-01125 A05I-01126 A05I-01127 A05I-01128 A05I-01129 A05I-01130 A05I-01131 A05I-01132 A05I-01133 A05I-01134 A05I-01135 A05I-01136 A05I-01137 A05I-01138 A05I-01139 A05I-01140 A05I-01141 A05I-01142 A05I-01143 A05I-01144 A05I-01145 A05I-01146 A05I-01147 A05I-01148 A05I-01149 A05I-01150 A05I-01151 A05I-01152 A05I-01153 A05I-01154 A05I-01155 A05I-01156 A05I-01159 A05I-01160 A05I-01161 A05I-01162 A05I-01163 A05I-01164 A05I-01165 A05I-01166 A05I-01167 A05I-01168 A05I-01169 A05I-01170 A05I-01171 A05I-01172 A05I-01173 A05I-01174 A05I-01175 A05I-01176 A05I-01177 A05I-01178 A05I-01179 A05I-01180 A05I-01181 A05I-01182 A05I-01183 A05I-01184 A05I-01185 A05I-01186 A05I-01187 A05I-01188 A05I-01189 A05I-01190 A05I-01191 A05I-01192 A05I-01193 A05I-01196 A05I-01197 A05I-01198 A05I-01199 A05I-01200 A05I-01201 A05I-01202 A05I-01203 A05I-01204 A05I-01205 A05I-01207 A05I-01209 A05I-01210 A05I-01211 A05I-01212 A05I-01213 A05I-01214 A05I-01215 A05I-01216 A05I-01217 A05I-01218 A05I-01219 A05I-01220 A05I-01221 A05I-01222 A05I-01223 A05I-01224 A05I-01225 A05I-01226 A05I-01227 A05I-01228 A05I-01229 A05I-01230 A05I-01232 A05I-01234 A05I-01235 A05I-01236 A05I-01237 A05I-01238 A05I-01239 A05I-01240 A05I-01241 A05I-01242 A05I-01243 A05I-01244 A05I-01245 A05I-01247 A05I-01248 A05I-01249 A05I-01250 A05I-01251 A05I-01252 A05I-01253 A05I-01254 A05I-01255 A05I-01256 A05I-01258 A05I-01259 A05I-01260 A05I-01261 A05I-01262 A05I-01263 A05I-01264 A05I-01265 A05I-01266 A05I-01268 A05I-01269 A05I-01270 A05I-01271 A05I-01272 A05I-01273 A05I-01274 A05I-01275 A05I-01276 A05I-01277 A05I-01278 A05I-01279 A05I-01281 A05I-01282 A05I-01284 A05I-01285 A05I-01286 A05I-01287 A05I-01291 A05I-01294 A05I-01297 A05I-01300 A05I-01301 A05I-01302 A05I-01303 A05I-01304 A05I-01305 A05I-01307 A05I-01308 A05I-01309 A05I-01310 A05I-01311 A05I-01312 A05I-01313 A05I-01314 A05I-01315 A05I-01316 A05I-01317 A05I-01318 A05I-01319 A05I-01320 A05I-01321 A05I-01322 A05I-01324 A05I-01325 A05I-01327 A05I-01328 A05I-01330 A05I-01331 A05I-01332 A05I-01333 A05I-01334 A05I-01335 A05I-01336 A05I-01337 A05I-01338 A05I-01339 A05I-01340 A05I-01341 A05I-01342 A05I-01343 A05I-01344 A05I-01347 A05I-01348 A05I-01349 A05I-01350 A05I-01351 A05I-01352 A05I-01354 A05I-01355 A05I-01356 A05I-01358 A05I-01359 A05I-01360 A05I-01361 A05I-01362 A05I-01363 A05I-01365 A05I-01366 A05I-01367 A05I-01368 A05I-01369 A05I-01370 A05I-01372 A05I-01373 A05I-01374 A05I-01375 A05I-01376 A05I-01377 A05I-01378 A05I-01379 A05I-01382 A05I-01383 A05I-01384 A05I-01385 A05I-01386 A05I-01387 A05I-01388 A05I-01389 A05I-01390 A05I-01391 A05I-01392 A05I-01393 A05I-01394 A05I-01395 A05I-01396 A05I-01398 A05I-01400 A05I-01401 A05I-01402 A05I-01404 A05I-01405 A05I-01406 A05I-01407 A05I-01408 A05I-01409 A05I-01410 A05I-01411 A05I-01412 A05I-01413 A05I-01414 A05I-01416 A05I-01417 A05I-01418 A05I-01419 A05I-01420 A05I-01421 A05I-01423 A05I-01424 A05I-01425 A05I-01426 A05I-01427 A05I-01428 A05I-01429 A05I-01430 A05I-01431 A05I-01432 A05I-01433 A05I-01434 A05I-01435 A05I-01436 A05I-01437 A05I-01438 A05I-01440 A05I-01441 A05I-01442 A05I-01443 A05I-01445 A05I-01446 A05I-01447 A05I-01448 A05I-01449 A05I-01451 A05I-01452 A05I-01453 A05I-01454 A05I-01455 A05I-01456 A05I-01457 A05I-01458 A05I-01459 A05I-01460 A05I-01461 A05I-01462 A05I-01464 A05I-01465 A05I-01466 A05I-01467 A05I-01468 A05I-01469 A05I-01470 A05I-01471 A05I-01472 A05I-01473 A05I-01474 A05I-01475 A05I-01476 A05I-01477 A05I-01478 A05I-01479 A05I-01480 A05I-01481 A05I-01482 A05I-01483 A05I-01484 A05I-01485 A05I-01486 A05I-01488 A05I-01489 A05I-01490 A05I-01491 A05I-01492 A05I-01493 A05I-01495 A05I-01496 A05I-01498 A05I-01499 A05I-01500 A05I-01504 A05I-01505 A05I-01508 A05I-01509 A05I-01510 A05I-01511 A05I-01512 A05I-01514 A05I-01515 A05I-01516 A05I-01518 A05I-01519 A05I-01523 A05I-01526 A05I-01527 A05I-01528 A05I-
Recalling Firm/
Manufacturer
Philips Medical Systems
2301 5th Ave Ste 200
Seattle WA 98121
206-664-5290
For Additional Information Contact Dennis Daniels
206-664-5000
Manufacturer Reason
for Recall
Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.
FDA Determined
Cause 2
Component design/selection
Action Three separate Urgent - Device Recall letter were sent out on April 30, 2008 via tractable letter using UPS. 1) The end-customer letter advises of the recall, contact information to arrange a replacement of the device and instructions for checking the equipment to insure it is working correctly. "If your HeartStart Home Defibrillator is one of the affected devices or if you have any questions about this recall, please contact Philips Healthcare at 1.800.263.3342, option 5, or visit www.HeartStartHome.com to arrange for a free replacement defibrillator. If you have given your HeartStart to someone else as a gift, please call us promptly and let us know how to contact that person to arrange for the replacement. While waiting for your replacement unit, Philips recommends that you perform a battery insertion test (BLT) of your HeartStart, as described in the Owner's Manual provided with it. Simply remove the battery, wait 5 seconds, reinstall the battery, then press the shock button when directed. After the BIT has finished, press the green On/Off button twice. If either button does not seem to work, please contact Philips immediate." 2) The dealer/distributor and retail letters advises of the recall; request that the dealer/distributor provide end-customer information. "As part of a coordinated effort involving notification of regulatory authorities, other Philips entities, and support personnel, Philips will be contacting all affected customers directly. It is not necessary for you or your sub-distributors to contact customers." 3) The international customer contacts will be made via established Philips sales and distribution channels. Philips will be replacing international units under a Field Change Order Process (to be provided by the firm). In addition, Philips will provide a website that will provide customers with information related to the recall (www.HeartStartHome).
Quantity in Commerce 3,959 units
Distribution Worldwide including USA and countries of Austria, Australia, Canada, Colombia, German, Denmark, Dominican Republic, Spain, France, England, Ireland, Italy, Japan, Netherlands, Norway, New Zealand, Panama, Sweden, Singapore, and South Africa.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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