Z-0692-2019Class II

Dx-D 600 Direct Radiography System

Name: Z-0692-2019 Dx-D 600 Direct Radiography System
Creator: Agfa-Gevaert, N.V.
Published: 2018-12-04
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2018-12-04 / Terminated / root cause: software

FDA source

Agfa-Gevaert, N.V. began a recall of 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... on 2018-12-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0692-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-04
Posted: 2019-01-07
Terminated: 2020-04-24
Recalling firm: AGFA Healthcare Corp.
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.
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Field Safety Notice dated 12/4/18 was sent to customers. Actions undertaken by Agfa: Soon Agfa or its representative will visit your site and install the latest revision of the hardware board, which will prevent a movement without user interaction. Recommended actions to be taken by you: If you notice an Overhead Tube Crane movement without user interaction, notify your Agfa Service contact at once. Please distribute this information within your facility to all those who need to be aware of it. It is important to take the actions detailed in this Urgent Field Safety Notification and to acknowledge receipt of this notification.
Quantity in commerce: 10
Distribution: US Nationwide Distribution in the states: IN, KS, MA, SC, and VA.
Product codes and lots: Serial Numbers: A5430000015 A5430000020 A5430000030 A5430000042 A5430000052 A5430000061 A5430000066 A5430000067 A5430000079 A5430000081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0692-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0692-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-07

Product code KPR

K112670Class IIDx-D 600Agfa Healthcare N.V. / cleared 2011-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)