Device recall

Z-0537-2025: dS Breast 16ch 1.5T

FDA device recall · Class II · Philips North America Llc

Key facts

Recall number (Z-number) Z-0537-2025
Recall event 95645
Product dS Breast 16ch 1.5T
Product code MOS
Recalling firm Philips North America Llc
Recall class Class II
Status Open, Classified
510(k) numbers K072873
FEI number 3016618143

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 10–99 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)