Recall Z-1745-2015— AGFA Healthcare Corp.

Name: FDA recall Z-1745-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-29

Class II · Terminated

Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2015-05-29, terminated 2017-01-18. It names one FDA 510(k) clearance: K103597. Product: AGFA DX-D 100 is a mobile digital radiography x-ray system. Reason: When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur..

Recalling firm: AGFA Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Terminated: 2017-01-18
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K103597 — DX-D 100Agfa Healthcare N.V.·cleared 2011-01-03

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

AGFA DX-D 100 is a mobile digital radiography x-ray system

Reason for recall

When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.

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