FDAFDA · Food and drugs·Recall number Z-0862-2024
Senographe Pristina
Published February 14, 2024 · Recall initiated: December 26, 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
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- GE Medical Systems, SCS
- Distributor
- Us Nationwide-Worldwide Distribution
- Lot
- GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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