FDA Medical Device Recalls (openFDA)
Carestream Health, Inc.: Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
- Recall number
- Z-0126-2014
- Recalling firm
- Carestream Health, Inc.
- Product
- Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
- Status
- Terminated
- Initiated
- 2013-06-06
- Posted
- 2013-10-31
- Terminated
- 2016-05-20
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 180 units
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K120062"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 1315356
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28