Recall archive / FDA device enforcement
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (... — FDA record Z-1533-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 4, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
- Classification
- Class I
- Recalling firm
- ZOLL Circulation, Inc.
- Quantity
- 91
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1533-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 23, 2025
- Recall initiation date
- Mar 4, 2025
- Center classification date
- Apr 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.