The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0796-2014·Announced 2014-01-29

Carestream DRX-Evolution X-Ray Systems Recalled for Unexpected Movement

Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 systems due to a risk of unexpected device movement.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 unexpected movement of a heavy medical device, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

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

The recall affects 675 units in total, with 145 units distributed domestically in the United States and 530 units distributed internationally. The devices were distributed nationwide in the US, including 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 source text does not specify the exact actions consumers or facility operators should take, nor does it report any specific injuries or illnesses associated with the recall. The hazard is identified as the potential for unexpected device movement.

The recalled product

Product
DRX-Evolution with FF 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…
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 (1)

  • 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 →

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