Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
Recall
- Recall Number
- Z-0451-2016
- Event Number
- 72683
- Firm
- Shimadzu Medical Systems
- FEI Number
- 1000125362
- Product Code
- IZL
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 10, 2015
- Terminated
- October 27, 2016
- Address
- 20101 S Vermont Ave, Torrance, CA, 90502-1328
Description
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Shimadzu sent an Urgent Voluntary Medical Device Recall Notice dated November 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to customers to inform them that Shimadzu is recalling the Mobile X-ray system MobileDaRt Evolution because of reports that an image was not transferred to image server properly. Customers with questions are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
US Distribution and Internationally to Canada
297 units