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Codonics Horizon® Multi-media Imager

CODONICS INC. · Model 52C · UDI-DI 00814905020175

LMC Prescription
1
510(k) clearances
6
Adverse events (2 deaths)
3
Recalls
19
Facilities

Description

Grayscale Desktop Large Format Film and Paper Diagnostic Imager - 52C

Recalls

DateFirmReason
2015-03-11Philips Medical Systems (Cleveland) IncThe firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
2008-05-16AGFA Corp.The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
2003-11-25AGFA Corp.The GS1 circuit board may fail resulting in smoke or fire.

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Data 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.