Device recall

Z-1904-2021: Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product…

FDA device recall · Class II · Philips Medical Systems Nederlands

Key facts

Recall number (Z-number) Z-1904-2021
Recall event 87978
Product Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Product code OWB
Recalling firm Philips Medical Systems Nederlands
Recall class Class II
Status Terminated
Termination date Feb 8, 2023
510(k) numbers K141979
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)