Recall Z-0126-2014 ยท IZL System, X-Ray, Mobile
Carestream Health, Inc.
Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
| Date | Oct 31, 2013 (initiated Jun 6, 2013) |
| Status | Terminated |
| 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 Cares |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM Carestream Health, Inc., Apr 13, 2012 |