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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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, bat
- Manufacturer
- ZOLL Circulation, Inc.
- Affected units
- 91
Distribution
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