Carestream DRX-Revolution Mobile X-ray System recallZ-0126-2014 · Carestream Health, Inc. · initiated Jun 6, 2013
Class II Terminated All recalls posted in October 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carestream Health, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.
FDA root cause category: Device Design
What the company is doing
On June 6, 2013 Carestream Health Inc. initiated a recall for the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. Carestream Health Inc. will replace the power plug in all potentially impacted DRX-Revolution Mobile X-Ray Systems. Your Carestream service representative will contact you to answer any questions and schedule a visit to replace the plug of your Mobile X-Ray System as soon as possible. If you have any questions or concerns, or if you experience any issue with your plug prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
Recall details
- Recall number
- Z-0126-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 6, 2013
- Posted by the FDA
- Oct 31, 2013
- Recalling firm
- Carestream Health, Inc.
- Quantity
- 180 units
- Product code
- IZL
- FDA submissions
- K120062
- Distribution
- Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.
Product description
Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Code information (models, lots, serial numbers)
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, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490
Other devices under the same FDA submission
1 device cleared under K120062 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · System, x-ray, mobile2 recalls12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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