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Carestream Health Inc. recalls DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty,
Recalled November 13, 2013 · FDA recall Z-0132-2014 · Carestream Health
Hazard
Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column. · FDA Class II
Units
331 units
Sold at
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.
Description
Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
Product
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
Manufacturer(s)
Carestream Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →