GE HEALTHCARE AUSTRIA GMBH & CO 2024-02-07 Health serious FDA
Health · FDA · Recall #FDA-Z-0865-2024
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound… Recall
Issued February 7, 2024 · GE HEALTHCARE AUSTRIA GMBH & CO
In February 2024, GE HEALTHCARE AUSTRIA GMBH & CO recalled the GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE HEALTHCARE AUSTRIA GMBH & CO to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE HEALTHCARE AUSTRIA GMBH & CO
- Category
- Health
- Recall date
- February 7, 2024
- Units affected
- Not reported
- Sold at
- worldwide
- Recall number
- FDA-Z-0865-2024
- Made in
- Austria
- Issuing agency
- FDA
In context
- GE HEALTHCARE AUSTRIA GMBH & CO has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.