Class II — AGFA Healthcare Corp.
| Recalling firm | AGFA HEALTHCARE N.V. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement. |
| Product | DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts. |
| Quantity | 17 units |
| Distribution | Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada |
| Initiated | 2014-07-02 |
| Classified | 2014-08-09 |
| Terminated | 2015-06-04 |
| Recall number | Z-2175-2014 |
| 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 Healthcare Corp. (Z-2175-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68752/
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