Device recall

Z-2058-2025: Philips S5-1 Transducer.

FDA device recall · Class II · Philips Ultrasound, Inc

Key facts

Recall number (Z-number) Z-2058-2025
Recall event 96994
Product Philips S5-1 Transducer.
Product code ITX
Recalling firm Philips Ultrasound, Inc
Recall class Class II
Status Open, Classified
510(k) numbers K042540, K081802, K091804, K111513, K123754
FEI number 2518586

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)