Device recall

Z-0541-2010: GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic…

FDA device recall · Class II · GE Medical Systems, LLC

Key facts

Recall number (Z-number) Z-0541-2010
Recall event 53519
Product GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems
Product code IYO
Recalling firm GE Medical Systems, LLC
Recall class Class II
Status Terminated
Termination date Dec 17, 2011
510(k) numbers K061682
FEI number 2126677

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)