Recall Z-0692-2019— Agfa-Gevaert, N.V.

Name: FDA recall Z-0692-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-04

Class II · Terminated

Class II FDA medical device recall by Agfa-Gevaert, N.V., initiated 2018-12-04, terminated 2020-04-24. It names one FDA 510(k) clearance: K112670. 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.. 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..

Recalling firm: Agfa-Gevaert, N.V.
Classification: Class II
Status: Terminated
Initiated: 2018-12-04
Terminated: 2020-04-24
Firm location: Kontich, Belgium

510(k) clearances named in this recall

1 on FDA's record

K112670 — DX-D 600Agfa Healthcare N.V.·cleared 2011-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.