Device recall

Z-0356-04: Access AED and Access ALS Automated External Defibrillators Model No…

FDA device recall · Class II · Access CardioSystems

Key facts

Recall number (Z-number) Z-0356-04
Recall event 27992
Product Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100
Product code MKJ
Recalling firm Access CardioSystems
Recall class Class II
Status Terminated
Termination date Jul 13, 2004
510(k) numbers K020984
FEI number 3003585458

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)