Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2175-2014

July 02, 2014

Class II

Product summary

Firm
AGFA Healthcare Corp.
Event
Event 68752
Status
Terminated
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-2175-2014

Official wording

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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.