GE Voluson IC9-RS Ultrasound Probes Recalled for Double Image Artifacts
GE HealthCare is recalling certain IC9-RS intracavitary ultrasound probes due to a double image artifact that creates ghost images. This unrecognized artifact can lead to diagnostic errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a risk-of-harm product (diagnostic imaging equipment with potential to cause diagnostic errors), but no illnesses, injuries, or adverse events have been reported. Per the recall severity rubric, risk-of-harm products without reported injury are scored as High.
Plain-English summary
GE HealthCare is recalling certain Voluson IC9-RS intracavitary ultrasound probes (Model Number J48691PJ) that are used for diagnostic ultrasound imaging and fluid flow analysis.
The probes can produce a double image artifact that creates a ghost image with realistic features in ultrasound images. If this artifact goes unrecognized, it may lead to diagnostic errors or misinterpretation of ultrasound findings.
Approximately 12,004 units have been distributed worldwide. Affected probes can be identified by serial number, which are listed in the FDA recall notice. The product identifier is UDI/DI 00840682105026112303002.
Healthcare providers should immediately review their inventory, identify affected units using the provided serial numbers, and take appropriate action based on guidance from GE HealthCare and the FDA.
The recalled product
- Product
- GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
- Manufacturer
- GE HEALTHCARE AUSTRIA GMBH & CO
- Affected units
- 12,004
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00840682105026112303002
- Serial Numbers: 1222552WX0
- 1263125WX5
- 1066771WX5
- 1191105WX4
- 1098079WX5
- 1108318WX5
- 1213744WX4
- 1101633WX4
- 1255114WX9
- 1278312WX2
- 1148860WX8
- 1194288WX5
- 1245514WX3
- 1260097WX9
- 1086878WX4
- 1193938WX6
- 1214142WX0
- 1214224WX6
- 1250333WX0
Distribution
Distribution scope not specified by the agency.
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