Reported Jan 15, 2014 · Terminated

Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester,…

Carestream Health Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carestream Health Inc. · 150 Verona St · Rochester, NY · 14608-1733

Is this the product you have?

  • Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Lot codes and dates
  • DRX Revolution Mobile X-Ray Systems manufactured
  • from June 2012 through October 2013

    310 of 310 codes

    • Serial Numbers DRXR00690
    • 111
    • 114
    • 119
    • 121
    • 122
    • 123
    • 125
    • 126
    • 134
    • 142
    • 143
    • 151
    • 152
    • 153
    • 154
    • 155
    • 161
    • 162
    • 163
    • 164
    • 165
    • 166
    • 167
    • 168
    • 169
    • 173
    • 174
    • 176
    • 177
    • 178
    • 180
    • 181
    • 182
    • 183
    • 188
    • 189
    • 190
    • 191
    • 192
    • 196
    • 197
    • 198
    • 199
    • 201
    • 202
    • 203
    • 205
    • 206
    • 207
    • 208
    • 209
    • 211
    • 221
    • 222
    • 223
    • 224
    • 225
    • 226
    • 227
Amount recalled
310 systerms domestically

Where it was sold

  • Nationwide

Why it was recalled

It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 18, 2015 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.