DRX Revolution Mobile X-Ray System

Unexpected failure of electrical components within the CPI generator.

Consignees were sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" on 10/02/2023. This notice requested that consignees inform all personnel that utilize the affected devices of the recall notice and to return the provided Consignee Notification Acknowledgement form completed. If a failure similar to the one associated with this recall event were to occur, users should move the system away from patients and staff, the system should be identified as inoperable, and a call should be made to Carestream Customer Care at 1-800-328-2910, your local service support number, or your Carestream Health Authorized Representative to schedule a service call. Customers with any questions are to call the Carestream Customer Care Center. If you have any questions or concerns please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24-hour basis. Outside of the U.S., please call your local Carestream Service support number.