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

FDA device recall Z-0865-2024 · posted 2024-01-30 · Open, Classified

Recall details

Recalling firm

GE HEALTHCARE AUSTRIA GMBH & CO

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.

Action taken

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/22/2023 via letter delivered using traceable means. The notice explained the issue with the device, safety issue, and requested the following actions be taken: 1. Ensure all potential users in your facility are made aware of this correction notification and the recommended actions. 2. You can continue to use your ultrasound system with all other probes. 3. Upon receipt of the letter, verify if your IC9-RS probe is functioning correctly prior to use by performing the Double Image artifact test provided in the letter. (Testing must be repeated monthly) 4. If a double image artifact is seen, do not use the probe and contact a GE HealthCare representative to get a replacement probe. 5. Complete and return the attached acknowledgement form to Recall.79072@ge.com. Please retain this document for your records.

Root cause

Device Design

Status

Open, Classified

Product code

IYN

Quantity affected

12004 units

Distribution

worldwide

Date initiated

2023-12-22

Date posted

2024-01-30

Location

Pfaffing, Austria

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