Device recall

Z-1155-2014: Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A…

FDA device recall · Class II · Philips Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-1155-2014
Recall event 67473
Product Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Product code MKJ
Recalling firm Philips Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Sep 11, 2020
FEI number 1218950

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)