Recall Z-1738-2017— AGFA Healthcare Corp.

Name: FDA recall Z-1738-2017
Creator: U.S. Food and Drug Administration
Published: 2016-05-02

Class II · Terminated

Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2016-05-02, terminated 2017-04-10. It names one FDA 510(k) clearance: K112670. Product: DX-D600 - DXD Imaging Package. Reason: One of the dent markers from the DX-D600 dropped down from the overhead rail..

Recalling firm: AGFA Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Terminated: 2017-04-10
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K112670 — DX-D 600Agfa Healthcare N.V.·cleared 2011-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DX-D600 - DXD Imaging Package

Reason for recall

One of the dent markers from the DX-D600 dropped down from the overhead rail.

Data sourced from openFDA. This site is unofficial and independent of the FDA.