Z-2175-2014 Class II Terminated

Recalled by AGFA Healthcare Corp. — Greenville, SC

Recall Details

Product Type
Devices
Report Date
August 20, 2014
Initiation Date
July 2, 2014
Termination Date
June 4, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units

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.

Distribution Pattern

Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada

Code Information

Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105