Z-0692-2019 Class II Terminated

Recalled by Agfa-Gevaert, N.V. — Kontich

Recall Details

Product Type
Devices
Report Date
January 16, 2019
Initiation Date
December 4, 2018
Termination Date
April 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

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