Device recall

Z-2134-2020: Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an…

FDA device recall · Class II · Philips North America, LLC

Key facts

Recall number (Z-number) Z-2134-2020
Recall event 85571
Product Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to transmit a controlled…
Product code MKJ
Recalling firm Philips North America, LLC
Recall class Class II
Status Terminated
Termination date Apr 2, 2021
510(k) numbers K021453
FEI number 1218950

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)