GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Recall
- Recall Number
- Z-0865-2024
- Event Number
- 93727
- Firm
- GE HEALTHCARE AUSTRIA GMBH & CO Tiefenbach 15 Pfaffing Austria
- FEI Number
- 3004377820
- Product Code
- IYN
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 22, 2023
- Posted
- January 30, 2024
Description
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
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.
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 [email protected]. Please retain this document for your records.
worldwide
12004 units