FDAFDA · Food and drugs·Recall number Z-2126-2023
GE Healthcare Vivid S60N, ultrasound device
Published July 19, 2023 · Recall initiated: May 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Vingmed Ultrasound As
- Distributor
- Worldwide distribution.
- Lot
- Software versions: v203, v204, v205, v206
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Norway
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