Recall Z-0451-2016 ยท IZL System, X-Ray, Mobile
Shimadzu Medical Systems
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.
| Date | Nov 10, 2015 |
| Status | Terminated |
| Reason | The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 297 units |
| Distribution | US Distribution and Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION Shimadzu Corp., May 14, 2008 |