Device recall

Z-0457-2016: DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure…

FDA device recall · Class III · BC Group International Inc

Key facts

Recall number (Z-number) Z-0457-2016
Recall event 72619
Product DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Product code DRL
Recalling firm BC Group International Inc
Recall class Class III
Status Terminated
Termination date Feb 15, 2017
510(k) numbers K110192
FEI number 2939012

At a glance

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