FDA Medical devices recall ·
AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1533-2025
- Date
- (initiated March 4, 2025)
- Company / brand
- ZOLL Circulation, Inc.
2000 Ringwood Ave, San Jose, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 91
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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,
States: Alabama California Connecticut Florida Illinois Kansas Louisiana Minnesota Missouri Montana North Carolina North Dakota New Mexico New York Ohio Oklahoma Pennsylvania Texas Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1533-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.