Device recall

Z-0284-2024: Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

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

Key facts

Recall number (Z-number) Z-0284-2024
Recall event 93218
Product Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Product code IYN
Recalling firm Philips Ultrasound, Inc.
Recall class Class II
Status Completed
510(k) numbers K231190
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)