Z-1533-2025Class I

Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number...

Name: Z-1533-2025 Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number...
Creator: ZOLL Circulation, Inc.
Published: 2025-03-04
License: https://open.fda.gov/license/

ZOLL Circulation, Inc. / initiated 2025-03-04 / Open, Classified

FDA source

ZOLL Circulation, Inc. began a recall of Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software... on 2025-03-04. FDA classified it as Class I and gives the reason as "AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1533-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-03-04
Posted: 2025-04-11
Recalling firm: ZOLL Circulation, Inc.
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
Product code: DRM Compressor, Cardiac, External
Reason for recall: AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
FDA root cause: Process change control
Action: On March 4, 2025, Zoll Circulation issued a "Medical Device Product Correction Notice" to affected consignees. Zoll asked consignees to take the following actions: 1. Stop using your affected platform(s) immediately. Your patients may not receive high-quality compressions. 2.Complete the Customer Acknowledgment/ No-Charge AP NXT Platform Repair Request Form (page 3)and email it to [email protected] within 3 days. Please feel free to call me at (408) 419 - 2955 if you have any questions. 3.Return your affected platform(s) to ZOLL as soon as you receive the loaner AP NXT Platform(s) from ZOLL.
Quantity in commerce: 91
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,
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1533-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1533-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-11

Product code DRM

K221700Class IIAutoPulse NXT Resuscitation SystemZoll Circulation, Inc. / cleared 2023-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)