PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 20, 2014 Initiated: July 2, 2014 #Z-2175-2014

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.

Details

Recalling Firm
AGFA Healthcare Corp.
Units Affected
17 units
Distribution
Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
Location
Greenville, SC

Frequently Asked Questions

What product was recalled?
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.. Recalled by AGFA Healthcare Corp.. Units affected: 17 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 20, 2014. Severity: Moderate. Recall number: Z-2175-2014.