FDAFDA · Food and drugs·Recall number Z-0865-2024
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Published February 7, 2024 · Recall initiated: December 22, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE HEALTHCARE AUSTRIA GMBH & CO
- Distributor
- worldwide
- Lot
- 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, 1263118WX0, 1148851WX7, 1165397WX9, 1165312WX8, 1148907WX7, 1025662WX6, 1148803WX8, 1148813WX7, 1148815WX2, 1154522WX5, 1101568WX2, 1101607WX8, 1165305WX2, 1123102WX4, 1086846WX1, 1086866WX9, 1060874WX3, 1244827WX0, 1132800WX2, 1135901WX5, 1154449WX1, 1123090WX1, 1159352WX2, 1229720WX6, 1148876WX4, 1240444WX8, 1101601WX1, 1194066WX5, 1131118WX0, 1086834WX7, 1226186WX3, 1229869WX1, 1274044WX5, 1274052WX8, 1025569WX3, 967727WX9, 967750WX1, 1229776WX8, 1244854WX4, 1255316WX0, 1255329WX3, 1101600WX3, 1232388WX7, 1244876WX7, 1097951WX6, 1237227WX2, 1244746WX2, 1025539WX6, 1025591WX7, 1066930WX7, 1078321WX5, 1123277WX4, 1136018WX7, 1136350WX4, 1154551WX4, 1158879WX5, 1158889WX4, 1158905WX8, 1158917WX3, 1164519WX9, 1165349WX0, 1165352WX4, 1165359WX9, 1165372WX2, 1165373WX0, 1165386WX2, 1165394WX6, 1165403WX5, 1168346WX3, 1250287WX8, 1165400WX1, 1250280WX3, 1075131WX1, 1078177WX1, 1035103WX9, 1222460WX6, 1222556WX1, 1214070WX3, 1179175WX3, 1213915WX0, 1154506WX8, 1154516WX7, 933488WX9, 1213770WX9, 1136118WX5, 1143343WX0, 1147961WX5, 1240441WX4, 1244766WX0, 1159101WX3, 1213942WX4, 1232509WX8, 1237182WX9, 1237189WX4, 1226193WX9, 1123136WX2, 1132813WX5, 1135915WX5, 1148816WX0, 1148880WX6, 1101599WX7, 1101608WX6, 1237164WX7, 1237263WX7, 1025309WX4, 1194129WX1, 1194133WX3, 1101583WX1, 1240579WX1, 1209207WX8, 1231609WX7, 1056706WX3, 1057218WX8, 1060827WX1, 1066942WX2, 1066944WX8, 1154430WX1, 1164509WX0, 1188537WX3, 1240050WX3, 1240098WX2, 1240412WX5, 1240418WX2, 1240440WX6, 1240051WX1, 1240057WX8, 1240071WX9, 1086781WX0, 1086863WX6, 1086877WX6, 1086944WX4, 1089846WX8, 1089859WX1, 1089861WX7, 1089862WX5, 1089880WX7, 1089901WX1, 1094005WX4, 1097957WX3, 1158862WX1, 1214046WX3, 1214051WX3, 1159355WX5, 1255327WX7, 1056745WX1, 1067038WX8, 1078404WX9, 1078470WX0, 1086931WX1, 1089740WX3, 1089918WX5, 1098142WX1, 1108418WX3, 1108448WX0, 1188556WX3, 1194110WX1, 1194118WX4, 1194135WX8, 1194143WX2, 1025525WX5, 1117240WX0, 1240421WX6, 1086888WX3, 1098154WX6, 1194161WX4, 1263102WX4, 1263112WX3, 1263141WX2, 1148782WX4, 1148810WX3, 1148824WX4, 1154565WX4, 1214312WX9, 1214321WX0, 1083766WX4, 1086881WX8, 1086906WX3, 1086910WX5, 1098035WX7, 1098095WX1, 1098099WX3, 1098103WX3, 1098116WX5, 1098131WX4, 1098137WX1, 1101428WX9, 1102486WX6, 1102489WX0, 1102491WX6, 1194269WX5, 967828WX5, 1240537WX9, 1237280WX1, 1148828WX5, 1213948WX1, 1136190WX4, 1159257WX3, 1240479WX4, 1250332WX2, 1255308WX7, 1123499WX4, 1131107WX3, 1154413WX7, 1240384WX6, 1244717WX3, 1083740WX9, 1094054WX2, 1057029WX9, 1232466WX1, 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Austria
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