The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0126-2014·Announced 2013-11-06

Carestream DRX-Revolution Mobile X-ray System Recalled for Sparking Power Plug

Carestream Health is recalling 180 DRX-Revolution Mobile X-ray Systems because the power plug generates sparks and becomes warm to the touch.

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 (electrical sparking and heat) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Carestream Health, Inc. is recalling 180 units of the DRX-Revolution Mobile X-ray System. The recall is due to a defect in the power plug, which has been observed generating sparks and becoming warm to the touch.

The affected units were distributed nationwide, including in New York, Texas, Pennsylvania, Ohio, Wisconsin, California, Illinois, Colorado, Florida, Indiana, Oklahoma, New Jersey, Georgia, Louisiana, Alabama, Kansas, Arizona, Massachusetts, South Carolina, Michigan, North Carolina, Iowa, Utah, Virginia, Tennessee, and Minnesota. The recall covers specific serial numbers ranging from 111 to 490.

Healthcare facilities and users should stop using the affected systems and contact Carestream Health for instructions on repair or replacement. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product
Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Manufacturer
Carestream Health, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
180

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 (20)

  • Serial Numbers: 111
  • 114
  • 119-123
  • 125-126
  • 134
  • 142-143
  • 151-155
  • 161-169
  • 173-178
  • 180-183
  • 188-192
  • 196-209
  • 211
  • 221-232
  • 235-249
  • 254
  • 261-270
  • 275-276
  • 279-286
  • 305

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

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