DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty,

FDA device recall Z-0132-2014 · posted 2013-11-01 · Terminated

Recall details

Recalling firm

Carestream Health Inc.

Reason for recall

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.

Action taken

The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible. If you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.

Root cause

Device Design

Status

Terminated

Product code

IZL

Quantity affected

331 units

Distribution

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 o

Date initiated

2013-06-19

Date posted

2013-11-01

Date terminated

2016-05-20

Location

Rochester, NY

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