Home / Recalls / Medical Devices
Carestream Health Inc. recalls Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnos
Recalled February 5, 2014 · FDA recall Z-0774-2014 · Carestream Health
Hazard
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. · FDA Class II
Units
4 units
Sold at
Nationwide Distribution including TX, IL, and GA.
Description
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.
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.
Manufacturer(s)
Carestream Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →