Skip to content
Recall Observatory FDA recall evidence

Device product

DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

Z-0692-2019

December 04, 2018

Class II

Product summary

Firm
Agfa-Gevaert, N.V.
Event
Event 81780
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-0692-2019

Official wording

Reason: After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position.

Code information: Serial Numbers: A5430000015 A5430000020 A5430000030 A5430000042 A5430000052 A5430000061 A5430000066 A5430000067 A5430000079 A5430000081

Distribution pattern: US Nationwide Distribution in the states: IN, KS, MA, SC, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position.