Kontich, Belgium
Agfa-Gevaert, N.V. recalls
1 recall recorded since 2018, most recently on 4 December 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 4 December 2018
- Terminated
- 24 April 2020
- 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.
- Distribution
- US Nationwide Distribution in the states: IN, KS, MA, SC, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0692-2019
- 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 ra
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.