Class 2 Device Recall HeartStart FR3 Defibrillator

• Date Initiated by Firm: October 10, 2018
• Create Date: October 18, 2018
• Recall Status: Terminated on August 19, 2022
• Recall Number: Z-0175-2019
• Recall Event ID: 81134
• PMA Number: P160028
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Philips HeartStart FR3 Defibrillator, Model: 861388, 861389; ; Product Usage:; The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.
• Code Information: Serial Numbers of affected AEDs begin with C16J, C16K, C17A, or C17B. Serial Numbers: C17B-00171 C17A-01227 C17A-01349 C17A-01361 C17B-00322 C17B-00323 C17B-00360 C17B-00172 C16K-01024 C17A-01356 C17A-01382 C17B-00038 C17A-01152 C16K-00726 C17A-01154 C17B-00101 C17B-00102 C17B-00104 C17B-00105 C17B-00107 C17B-00109 C17B-00110 C17B-00111 C17B-00112 C17B-00113 C17B-00114 C17B-00115 C17B-00116 C17B-00117 C17B-00118 C17B-00119 C17B-00125 C17B-00127 C17B-00132 C17B-00133 C17B-00143 C17B-00145 C17B-00158 C17B-00159 C17B-00160 C17B-00163 C16K-00495 C16K-00952 C16K-01029 C17B-00025 C17B-00057 C17B-00059 C17B-00069 C17B-00070 C17B-00071 C17B-00074 C17B-00077 C17B-00082 C17B-00083 C17B-00084 C17B-00089 C17B-00090 C17B-00098 C17B-00173 C17B-00178 C17B-00324 C17B-00120 C17B-00122 C17B-00123 C17B-00124 C17B-00126 C17B-00128 C17B-00129 C17B-00130 C17B-00131 C17B-00134 C17B-00135 C17B-00136 C17B-00137 C17B-00138 C17B-00139 C17B-00140 C17B-00141 C17B-00149 C17B-00150 C17B-00151 C17B-00152 C17B-00153 C17B-00154 C17B-00155 C17B-00156 C17B-00161 C17B-00167 C17B-00169 C17B-00170 C17B-00174 C17B-00175 C17B-00176 C17B-00177 C17B-00179 C17B-00181 C17B-00183 C17B-00185 C17B-00186 C17B-00188 C17B-00189 C17B-00191 C17B-00192 C17B-00193 C17B-00194 C17B-00195 C17B-00196 C17B-00197 C17B-00198 C17B-00199 C17B-00200 C17B-00201 C17B-00202 C17B-00203 C17B-00204 C17B-00206 C17B-00207 C17B-00209 C17B-00210 C17B-00213 C17B-00215 C17B-00216 C17B-00218 C17B-00219 C17B-00223 C17B-00225 C17B-00226 C17B-00227 C17B-00228 C17B-00229 C17B-00232 C17B-00240 C17B-00243 C17B-00244 C17B-00245 C17B-00246 C17B-00247 C17B-00248 C17B-00255 C17B-00256 C17B-00257 C17B-00258 C17B-00259 C17B-00260 C17B-00261 C17B-00263 C17B-00264 C17B-00265 C17B-00266 C17B-00277 C17B-00278 C17B-00283 C17B-00287 C17A-01261 C17A-01262 C17A-01263 C17A-01265 C17A-01277 C17A-01292 C17A-01293 C17A-01295 C17A-01341 C17A-01343 C17A-01351 C17A-01354 C17A-01355 C17A-01357 C17A-01359 C17A-01360 C17A-01362 C17A-01366 C17A-01368 C17A-01371 C17A-01372 C17A-01376 C17A-01377 C17A-01384 C17A-01385 C17A-01386 C17B-00014 C17B-00015 C17B-00026 C17B-00029 C17B-00043 C17B-00044 C17B-00095 C17B-00166 C17B-00100 C16K-00497 C17B-00087 C17A-00833 C17A-00834 C17A-00835 C17A-00837 C17A-00838 C17A-00839 C17A-00840 C17A-00841 C17A-00842 C17A-00843 C17A-00844 C17A-00845 C17A-00846 C17A-00847 C17A-00848 C17A-00849 C17A-00852 C17A-00853 C17A-00854 C17A-00855 C17A-00856 C17A-00857 C17A-00858 C17A-00860 C17A-00881 C17A-00882 C17A-00883 C17A-00884 C17A-00885 C17A-00887 C17A-00888 C17A-00889 C17A-00890 C17B-00339 C17B-00344 C17B-00335 C17B-00345 C16J-01286 C17B-00329 C17B-00292 C17B-00293 C17B-00313 C17B-00317 C17B-00320 C17A-01267 C16K-00944 C17A-01297 C17B-00060 C17B-00062 C17B-00063 C17B-00078 C17B-00088 C17B-00092 C17B-00096 C17B-00299 C17B-00306 C17B-00321 C17B-00338 C17B-00359 C17B-00361 C17B-00362 C17B-00364 C17B-00367 C17B-00371 C17B-00373 C17B-00374 C17B-00375 C17B-00386 C17B-00387 C17B-00388 C17B-00389 C17B-00392 C17B-00393 C17B-00394 C17B-00395 C17B-00396 C17B-00398 C17B-00399 C17B-00400 C17B-00235 C17A-01381 C17B-00056 C17B-00289 C17B-00291 C17A-01342 C17A-01344 C17A-01358 C17A-01383 C17B-00013 C17B-00033 C17B-00302 C17B-00220 C17B-00308 C17B-00341 C17B-00030 C17B-00239 C16K-00790 C17B-00034 C17B-00085 C17B-00332 C17B-00334 C17B-00336 C17B-00343 C17B-00350 C17B-00351 C17B-00354 C17B-00355 C17B-00356 C17B-00357 C17B-00365 C17B-00369 C17B-00376 C17B-00378 C17B-00379 C17B-00380 C17B-00419 C17A-00426 C17B-00290 C17B-00295 C17B-00296 C17B-00372 C17B-00382 C17B-00383 C17B-00390 C17A-01271 C17A-01350 C17B-00012 C17B-00018 C17B-00020 C17B-00021 C17B-00027 C17B-00028 C17B-00035 C17B-00040 C17B-00041 C17B-00042 C17A-01353 C17A-01379 C17A-01380 C17B-00022 C17B-00047 C17B-00051 C17B-00052 C17B-00053 C17B-00054 C17B-00055 C17A-01346 C17A-01348 C17A-01352 C17A-01388 C17B-00024 C17B-00066 C17B-00067 C17B-00068 C17B-00073 C17B-00075 C17B-00080 C17B-00086 C17B-00091 C17B-00212 C17B-00222 C17B-00234 C17B-00249 C17B-00250 C17B-00251 C17B-00252 C17B-00253 C17B-00273 C17B-00275 C17B-00280 C17B-00286 C17B-00297 C17B-00298 C17B-00301 C17B-00303 C17B-00304 C17B-00305 C17B-00318 C17B-00331 C17B-00342 C17B-00348 C17B-00363 C17B-00366 C17B-00370 C17A-01345 C17B-00418 C16K-00903 C17A-00831 C17A-00886 C17A-01264 C17A-01294 C17A-01298 C17B-00093 C17B-00097 C17B-00368 C17B-00381 C17B-00385 C17B-00046 C17B-00554 C17B-00217 C17B-00236 C17B-00315 C17B-00039 C17B-00180 C17B-00406 C17B-00407 C17B-00440 C17A-01151 C17A-01153 C17A-01155 C17A-01156 C17A-01157 C17A-01158 C17A-01159 C17A-01160 C17A-01212 C17A-01213 C17A-01214 C17A-01215 C17A-01216 C17A-01217 C17A-01220 C17A-01222 C17A-01223 C17A-01224 C17A-01225 C17A-01226 C17A-01228 C17A-01230 C17A-01234 C17A-01240 C17A-01273 C17A-01274 C17A-01279 C17A-01280 C17A-01291 C17A-01299 C17A-01300 C17A-01365 C17A-01369 C17A-01370 C17B-00058
• Recalling Firm/ Manufacturer: Philips Electronics North America Corp.; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Customer Services; 1800-722-9377
• Manufacturer Reason for Recall: Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
• FDA Determined Cause: Device Design
• Action: On 10/10/2018, Urgent Medical Device Recall notices, which include Field Safety Notices, were mailed via certified mail to U.S. customers. The recalling firm's Key Markets are responsible for distributing the letters outside of the U.S. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction Notification/Field Safety Notice: 1) Identify the AEDs affected by this Field Safety Notice by checking the serial numbers. 2) You may continue to use your present device until a replacement AED is provided from the firm if you take precautions to prevent your device from being subjected to a pressurized water stream. 3) Please ensure that any owner or program manager of an affected device is promptly made aware of this notification. If you have transferred the device to another person, please forward a copy of this notice to that person and notify the recalling firm of this transfer as soon as possible. Customers with additional questions can call the following number for assistance: 1-800-263-3342 option 5
• Quantity in Commerce: 432
• Distribution: Worldwide Distribution - U.S Nationwide in the states of: GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE; Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, United Kingdom
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.