Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
FDA device recall Z-0126-2014 · posted 2013-10-31 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 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.
- Date initiated
- 2013-06-06
- Date posted
- 2013-10-31
- Date terminated
- 2016-05-20
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRX-REVOLUTION MOBILE X-RAY SYSTEM (K120062) | Carestream Health, Inc. | 2012-04-13 |