Recall Z-2175-2014— AGFA Healthcare Corp.

Name: FDA recall Z-2175-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-02

Class II · Terminated

Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2014-07-02, terminated 2015-06-04. It names one FDA 510(k) clearance: K112670. 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 and other both parts.. Reason: Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement..

Recalling firm: AGFA Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-07-02
Terminated: 2015-06-04
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-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 and other both parts.

Reason for recall

Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.

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