Recall Z-0491-2014— Carestream Health Inc.
Class II · Terminated
Class II FDA medical device recall by Carestream Health Inc., initiated 2013-08-29, terminated 2015-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Carestream Health Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-29
- Terminated
- 2015-11-18
- Firm location
- Rochester, NY, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.