Recall Z-1369-2013 ยท IZL System, X-Ray, Mobile
Shimadzu Medical Systems
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
| Date | Jun 3, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| Reason | The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Shimadzu sent a recall letter dated March 18, 2013, to all customers who purchased the Shimadzu MobileDart Evolution in combination with CXDI-70C, CXDI-55C, or CXDI-55G. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to follow the instructions of the recall notice step by step. Customers with questions are instructed to contact their local Shimadzu representatives or contact Shimadzu National Technical Support at (800) 228-1429. A Field Safety Notice dated March 18, 2013, was sent to Service Managers in regards to the Shim |
| Quantity | 200 units |
| Distribution | US Nationwide Distribution |
| 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 |