Recall Z-0692-2019 ยท KPR System, X-Ray, Stationary
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, p
| Date | Dec 4, 2018 |
| Status | Terminated |
| 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 |
| Quantity | 10 |
| Distribution | US Nationwide Distribution in the states: IN, KS, MA, SC, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112670 | DX-D 600 Agfa Healthcare N.V., Oct 27, 2011 |