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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96479

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 04, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
ZOLL Circulation, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1533-2025
Recall number
Z-1533-2025
Initiated
March 04, 2025
Classification
Class I
Status
Ongoing
Recalling firm
ZOLL Circulation, Inc.
Quantity
91

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

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Inspect official wording and provenance

Reason for recall

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

Code information

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 pattern

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