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DRYPIX Plus
FUJIFILM CORPORATION · Model DRYPIX 4000 · UDI-DI 04547410180077
LMC
Prescription
1
510(k) clearances
6
Adverse events (2 deaths)
3
Recalls
19
Facilities
Description
The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging modalities, onto dedicated film in the selected format.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-11 | Philips Medical Systems (Cleveland) Inc | The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned. |
| 2008-05-16 | AGFA Corp. | The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON". |
| 2003-11-25 | AGFA Corp. | The GS1 circuit board may fail resulting in smoke or fire. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.