Device recall

Z-0353-2025: Philips Zenition 70, Model Number: 718133

FDA device recall · Class II · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Key facts

Recall number (Z-number) Z-0353-2025
Recall event 95579
Product Philips Zenition 70, Model Number: 718133
Product code OWB
Recalling firm PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall class Class II
Status Open, Classified
510(k) numbers K212813
FEI number 3002807880

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)