The Recall Desk
HighFDA (Devices)·Z-0797-2014·Announced 2014-01-29

Carestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk

Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 x-ray systems due to potential unexpected device movement.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (unexpected movement of heavy medical equipment) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Carestream Health, Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System. These products are permanently installed diagnostic x-ray systems used for the generation of x-rays for examination of various anatomical regions. The recall is due to the potential for unexpected device movement.

The recall affects 840 units total, with 181 units distributed domestically in the United States and 659 units distributed internationally. Domestic distribution includes states such as California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin. International distribution includes Australia, Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and the United Kingdom.

The affected devices are identified by Catalog Numbers 1731678, 1731660, 1010990, 1030451, 1016138, 1030477, 1010982, and 1030485, and Service Code 7171. The source text does not specify specific actions for consumers or healthcare providers to take, nor does it report any injuries or illnesses associated with the defect.

The recalled product

Product
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 ta
Manufacturer
Carestream Health, Inc.
Category
Medical Device — Diagnostic Imaging
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Carestream Health, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Carestream Health, Inc.

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Same hazard · unexpected movement

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