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FUJI IMAGING PLATE

FUJIFILM CORPORATION · Model IP-6 HR 24X30CM 2 M E · UDI-DI 04547410177121

EAM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.

Recalls

Date	Firm	Reason
2004-03-30	General Electric Med Systems	The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
2004-03-30	General Electric Med Systems	The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
2004-03-30	General Electric Med Systems	The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
2004-03-30	General Electric Med Systems	The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.

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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.