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DRX-Evolution with CSH WS recallZ-0797-2014 · Carestream Health, Inc. · initiated Nov 25, 2013

Class II Terminated All recalls posted in January 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Carestream Health, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0797-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 25, 2013
Posted by the FDA
Jan 21, 2014
Recalling firm
Carestream Health, Inc.
Quantity
840 units Total (181 units domestically & 659 units internationally)
Product code
IZL
FDA submissions
K091889
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, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

Product description

DRX-Evolution with CSH WS 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 wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Code information (models, lots, serial numbers)

Catalog Numbers: 1731678, 1731660, 1010990, 1030451, 1016138, 1030477, 1010982, 1030485; Service Code: 7171

Other devices under the same FDA submission

1 device cleared under K091889 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67047).

Sources and updates

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