CHROME

IcRco, Inc. · Model LF · UDI-DI 00854810007045

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Recalls

Facilities

Description

The iCRco Chrome LF is a high-resolution, tabletop computed radiography (CR) system designed for general digital radiography and orthopedic imaging. It utilizes a patented True Flat Scan Path technology that scans phosphor plates without internal rollers, reducing wear and extending plate longevity. The device supports standard 10x12 and 14x17 inch cassettes, delivers up to 16-bit grayscale image resolution, and interfaces with DICOM-compliant imaging networks

Recalls

Date	Firm	Reason
2019-09-25	Brainlab AG	The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if us
2005-03-30	Konica Medical Imaging, Inc.	One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.

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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.