Device recall

Z-3249-2026: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

FDA device recall · Class II · Philips Ultrasound, LLC

Key facts

Recall number (Z-number) Z-3249-2026
Recall event 99706
Product Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Product code IYN
Recalling firm Philips Ultrasound, LLC
Recall class Class II
Status Open, Classified
510(k) numbers K260123, K260680
FEI number 3019216

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)