Device recall

Z-1386-2024: Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX…

FDA device recall · Class II · Philips North America

Key facts

Recall number (Z-number) Z-1386-2024
Recall event 94185
Product Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Product code MHX
Recalling firm Philips North America
Recall class Class II
Status Open, Classified
510(k) numbers K153702
FEI number 3006648320

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)