Device recall

Z-2175-2014: DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing…

FDA device recall · Class II · AGFA Healthcare Corp.

Key facts

Recall number (Z-number) Z-2175-2014
Recall event 68752
Product DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen…
Product code KPR
Recalling firm AGFA Healthcare Corp.
Recall class Class II
Status Terminated
Termination date Jun 4, 2015
510(k) numbers K112670
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)