Device recall

Z-2176-2014: Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for…

FDA device recall · Class III · AGFA Healthcare Corp.

Key facts

Recall number (Z-number) Z-2176-2014
Recall event 68798
Product Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Product code IZL
Recalling firm AGFA Healthcare Corp.
Recall class Class III
Status Terminated
Termination date Aug 13, 2014
510(k) numbers K103597
FEI number 3001236302

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)