Device recall

Z-0559-2024: Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7…

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

Key facts

Recall number (Z-number) Z-0559-2024
Recall event 93416
Product Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Product code OWB
Recalling firm PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall class Class II
Status Open, Classified
510(k) numbers 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)