Device recall

Z-0865-2024: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic…

FDA device recall · Class II · GE HEALTHCARE AUSTRIA GMBH & CO

Key facts

Recall number (Z-number) Z-0865-2024
Recall event 93727
Product GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Product code IYN
Recalling firm GE HEALTHCARE AUSTRIA GMBH & CO
Recall class Class II
Status Open, Classified
510(k) numbers K160184
FEI number 3004377820

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)