Device recall

Z-0641-2007: Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED)…

FDA device recall · Class II · Philips Medical Systems

Key facts

Recall number (Z-number) Z-0641-2007
Recall event 37477
Product Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A
Product code MKJ
Recalling firm Philips Medical Systems
Recall class Class II
Status Terminated
Termination date Nov 13, 2013
510(k) numbers K003565
FEI number 1000524572

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)