CLASS II Device recall · Reported 16 Jan 2019 · FDA Enforcement Report
Dx-d 600 Direct Radiography System recalled by Agfa-Gevaert, N.V
Agfa-Gevaert, N.V is recalling Dx-d 600 Direct Radiography System, distributed nationwide in the US. The recall was initiated on 4 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0692-2019
- FDA event ID
- 81780
- Recalling firm
- Agfa-Gevaert, N.V, Kontich
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2018
- FDA classified
- 7 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 4 Dec 2018 | Recall initiated by company | |
| 7 Jan 2019 | Classified by FDA | +34 days |
| 16 Jan 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in the states: IN, KS, MA, SC, and VA.
Questions about this recall
Is Dx-d 600 Direct Radiography System recalled?
Yes. Agfa-Gevaert, N.V recalled Dx-d 600 Direct Radiography System on 4 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-0692-2019.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: A5430000015 A5430000020 A5430000030 A5430000042 A5430000052 A5430000061 A5430000066 A5430000067 A5430000079 A5430000081
Where was it sold?
US Nationwide Distribution in the states: IN, KS, MA, SC, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |