DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system… — Class II medical device recall Z-0692-2019
Terminated recall by Agfa-Gevaert, N.V., reported 2019-01-16, distributed nationwide. After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead T
| Recall number | Z-0692-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa-Gevaert, N.V., Kontich, Belgium |
| Recall initiated | 2018-12-04 |
| Classified | 2019-01-07 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Reason classes | software |
| Serial numbers | A5430000015, A5430000020, A5430000030, A5430000042, A5430000052, A5430000061, A5430000066, A5430000067, A5430000079, A5430000081 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0692-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.