Recall Z-0774-2014— Carestream Health Inc.

Class II FDA medical device recall by Carestream Health Inc., initiated 2013-08-20, terminated 2016-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.. Reason: Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor..

Recalling firm

Carestream Health Inc.

Classification

Class II

Status

Terminated

Initiated

2013-08-20

Terminated

2016-06-28

Firm location

Rochester, NY, United States

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