FDA Device recall Z-0865-2024

GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

FDA Device
Class II
ongoing
Published 2024-02-07

On 2024-02-07 the FDA classified a Class II recall of GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis by Ge Healthcare Austria And, citing 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 wit….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0865-2024
Classification	Class II
Status	ongoing
Initiated	2023-12-22
Published	2024-02-07
Last updated	2026-09-13 11:57 UTC
Company	Ge Healthcare Austria And
Distribution	n/a

Product

GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

Reason

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.

Identifiers

code_info	UDI/DI 00840682105026112303002, Serial Numbers: 1222552WX0, 1263125WX5, 1066771WX5, 1191105WX4, 1098079WX5, 1108318WX5… 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, 1194282W

code_info

UDI/DI 00840682105026112303002, Serial Numbers: 1222552WX0, 1263125WX5, 1066771WX5, 1191105WX4, 1098079WX5, 1108318WX5…

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, 1194282W

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0865-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.