GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.
Reason for recall: GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis. Distribution: worldwide Quantity: 12004 units Lot/code info: UDI/DI 00840682105026112303002, Serial Numbers: 1222552WX0, 1263125WX5, 1066771WX5, 1191105WX4, 1098079WX5, 1108318WX5, 1213744WX4, 1101633WX4, 1255114WX9, 1278312WX2, 1148860WX8, 1194288WX5, 1245514WX3, 1260097WX9, 1086878WX4, 1193938WX6, 1214142WX0, 1214224WX6, 1250333WX0, 1148798WX0, 967787WX3, 1240563WX5, 1086837WX0, 1056904WX4, 1240504WX9, 1240523WX9, 1078218WX3, 1164537WX1, 1164543WX9, 1164578WX5, 1165280WX7, 1226207WX7, 1200650WX8, 1204921WX9, 1209228WX4, 1209233WX4, 1209242WX5, 1209249WX0, 1194302WX4, 1083859WX7, 1136238WX1, 1232511WX4, 965764WX4, 1102510WX3, 1231617WX0, 1188541WX5, 1131135WX4, 1101581WX5, 933487WX1, 1089751WX0, 1094081WX5, 1244833WX8, 1265068WX5, 1191119WX5, 1083721WX9, 1086810WX7, 1089907WX8, 1123486WX1, 1131088WX5, 1131146WX1, 1269644WX9, 1240005WX7, 1240010WX7, 1263059WX6, 1269523WX5, 1057273WX3, 933496WX2, 1213935WX8, 1269599WX5, 1123553WX8, 1131123WX0, 1164520WX7, 1164581WX9, 1148835WX0, 1250262WX1, 1250264WX7, 1263106WX5, 990735WX3, 1191069WX2, 1194282WX8, 1143351WX3, 1089877WX3, 1089885WX6, 1278241WX3, 1278465WX8, 1159170WX8, 1179177WX9, 1188568WX8, 1209245WX8, 1108449WX8, 1164534WX8, 1164565WX2, 1269539WX1, 1226217WX6, 962655WX7, 1191100WX5, 1240408WX3, 1263093WX5, 1035106WX2, 1194124WX2, 1209205WX2, 1214218WX8, 1274014WX8, 1143364WX6, 1214050WX5, 1098089WX4, 1102447WX8, 1102475WX9, 1097980WX5, 1098057WX1, 1098090WX2, 1098138WX9, 1098168WX6, 1240462WX0, 1086887WX5, 1086895WX8, 1131110WX7, 1131120WX6, 1158860WX5, 1158865WX4, 1244831WX2, 126311
Official record: FDA (Device enforcement) ↗
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