Device recall

Z-2485-2023: Wireless Foot Switch distributed with Philips Allura Xper and Azurion…

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

Key facts

Recall number (Z-number) Z-2485-2023
Recall event 92782
Product Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Product code OWB
Recalling firm PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall class Class II
Status Open, Classified
510(k) numbers K161563, K200917
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)