Device recall

Z-0881-2022: Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH…

FDA device recall · Class II · Philips North America LLC

Key facts

Recall number (Z-number) Z-0881-2022
Recall event 89672
Product Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Product code MKJ
Recalling firm Philips North America LLC
Recall class Class II
Status Open, Classified
PMA numbers P160029
FEI number 1000524572

At a glance

  • None 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)