AutoPulse NXT Resuscitation System may fail to provide chest compressions
ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System Model 200 because the device may not provide adequate chest compressions or may stop compressions due to an error code FC1060.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I. A Class I recall is by definition a situation in which use of the device may cause serious adverse health consequences or death, and this device failure during resuscitation poses direct risk of serious injury or death. Therefore severity is Critical per the rubric.
Plain-English summary
ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System Model 200 (Catalog Number 8700-001070-1, Software Version 2.0.1) because the device may not provide adequate chest compressions or may stop compressions due to code FC1060. The AutoPulse NXT is an automated, portable, battery-powered device used to compress the chest of an adult as an adjunct to manual CPR during resuscitation.
Affected units have serial numbers: 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. The product was distributed in the United States and Canada and Hong Kong.
Healthcare providers and facilities using affected AutoPulse NXT devices should immediately inspect their units and contact ZOLL Circulation, Inc. for further guidance regarding remedy options. The FDA has classified this as a Class I recall.
The recalled product
- 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…
- Manufacturer
- ZOLL Circulation, Inc.
- Affected units
- 91
Distribution
Related recalls
Same manufacturer · ZOLL Circulation, Inc.
See all →- HighAutoPulse Resuscitation System Battery Recalled for Increased Li-ion Failures
FDA (Devices) · 2022-11-02
- HighZoll SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks
FDA (Devices) · 2021-10-13
- HighZOLL COOL LINE Intravascular Catheter Kit Recalled for Potential Leaks
FDA (Devices) · 2021-10-13
- HighZoll Intravascular Catheter Kit Labeling Update for Potential Leaks
FDA (Devices) · 2021-10-13
- HighZOLL Quattro IV therapy kit recalled due to potential catheter tubing leaks
FDA (Devices) · 2021-10-13
Same hazard · device malfunction
See all →- SevereVentec Ventilator Cable Recall Due to Potential Disconnection
FDA (Devices) · 2026-10-28
- SevereVentec VC+Pro Ventilator Recalled for Potential Connector Disconnection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim SureScan MRI Leads Recalled for Incompatible Selection
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
Similar recalls
- HighZoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops
FDA (Devices) · 2013-01-16
- HighAutoPulse Resuscitation System Battery Recalled for Increased Li-ion Failures
FDA (Devices) · 2022-11-02
- LowZoll Circulation Recalls AutoPulse Accessories Due to Japanese Label Typo
FDA (Devices) · 2014-07-30
- HighAtrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk
FDA (Devices) · 2014-01-22
- HighAtrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall
FDA (Devices) · 2014-01-22
- CriticalAccutron Recalls Flowmeter Packages for Incorrect Gas Function
FDA (Devices) · 2012-10-17