DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main component

FDA device recall Z-0797-2014 · posted 2014-01-21 · Terminated

Recall details

Recalling firm

Carestream Health, Inc.

Reason for recall

Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

Action taken

The firm, Carestream Health Inc, sent an "URGENT: Medical Device Recall" notice dated November 20, 2013 to their customers. The notice described the product, problem and actions to be taken. The customers were instructed that the Emergency Stop (E-Stop) button be used on the motorized FF WS and CSH WS Buckys for any observed uncontrolled movement as indicated in the user guide. If this movement is observed, please notify Carestream Health, and Carestream will schedule a site visit to resolve the problem. In addition, Carestream Health Inc. will apply a label(s) indicating the location of the E-stop button for customers using the FF WS. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IZL

Quantity affected

840 units Total (181 units domestically & 659 units internationally)

Distribution

Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, C

Date initiated

2013-11-25

Date posted

2014-01-21

Date terminated

2016-06-30

Location

Rochester, NY

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