BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

    Recall: Z-1533-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1533-2025
    Event ID
    96479
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ZOLL Circulation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2025
    Initiation Date
    March 4, 2025
    Classification Date
    April 11, 2025
    Address
    2000 Ringwood Ave, San Jose, CA, 95131-1728, United States

    Description

    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

    Reason

    AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

    Code Info

    UDI: (01) 00849111003384/Serial number: 1179 1168 1178 1184 1188 1197 1109 1110 1126 1166 1169 1152 1199 1202 1111 1185 1198 1203 1206 1208 1211 1212 1172 1182 1130 1128 1129 1189 1183 1131 1134 1191 1186 1192 1170 1173 1175 1180 1174 1176 1187 1177 1116 1165 1118 1119 1193 1138 1139 1145 1146 1147 1148 1149 1150 1153 1155 1159 1161 1162 1163 1164 1181 1141 1108 1190 1195 1120 1121 1122 1123 1107 1112 1113 1114 1115 1137 1140 1196

    Distribution

    US: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong,

    Quantity

    91