The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0798-2014·Announced 2014-01-29

Carestream DRX-Evolution and Kodak DirectView DR 7500 X-Ray Systems Recalled

Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 diagnostic x-ray systems due to a potential for 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-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 are permanently installed diagnostic x-ray systems used for the generation of x-rays for examination of various anatomical regions. The systems consist of an operator console, overhead tube crane, x-ray tube assembly, and stationary generator, and may also utilize an x-ray table and/or wallstand/bucky.

The recall is being conducted due to the potential for unexpected device movement. A total of 493 units are affected, with 107 units distributed domestically in the United States and 386 units distributed internationally. The affected units were distributed nationwide in the US and to various countries including 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.

Healthcare facilities and users of these devices should contact Carestream Health, Inc. for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
DR 7500 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 table…
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 (14)

  • Catalog Numbers: 8551046
  • 8791345
  • 1333483
  • 8649253
  • 8864605
  • 1155118
  • 1295088
  • 1666700
  • 1845122
  • 1671841
  • 8245607
  • 8531675
  • 8966780
  • Service Code: 8087

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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