FDA Medical Device Recalls (openFDA)
Agfa-Gevaert, N.V.: 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.
- Recall number
- Z-0692-2019
- Recalling firm
- Agfa-Gevaert, N.V.
- 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.
- Status
- Terminated
- Initiated
- 2018-12-04
- Posted
- not on file
- Terminated
- 2020-04-24
- 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.
- 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
- 10
- Distribution
- US Nationwide Distribution in the states: IN, KS, MA, SC, and VA.
- Lot, serial or model codes
- Serial Numbers: A5430000015 A5430000020 A5430000030 A5430000042 A5430000052 A5430000061 A5430000066 A5430000067 A5430000079 A5430000081
- 510(k) numbers
- ["K112670"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 3009471886
- Firm city
- Kontich
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28