Device recall

Z-0178-05: HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).

FDA device recall · Class II · Philips Ultrasound, Inc.

Key facts

Recall number (Z-number) Z-0178-05
Recall event 30160
Product HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
Product code IYN
Recalling firm Philips Ultrasound, Inc.
Recall class Class II
Status Terminated
Termination date Feb 9, 2006
510(k) numbers K002185
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)