Class II — Agfa-Gevaert, N.V.
| Recalling firm | Agfa Gevaert N.V. |
|---|---|
| Registered facility | Agfa Gevaert N.V. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 10 |
| Distribution | US Nationwide Distribution in the states: IN, KS, MA, SC, and VA. |
| Initiated | 2018-12-04 |
| Classified | 2019-01-07 |
| Terminated | 2020-04-24 |
| Recall number | Z-0692-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Agfa-Gevaert, N.V. (Z-0692-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81780/
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