Recall Z-1150-2014 ยท IZL System, X-Ray, Mobile
Shimadzu Medical Systems
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
| Date | Mar 7, 2014 (initiated Nov 15, 2013) |
| Status | Terminated |
| Reason | Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack. |
| Root cause | Nonconforming Material/Component |
| Action | A Field Safety Notice and an Urgent Voluntary Medical Device Recall Notice were sent to customers to inform them that SHIMADZU CORPORATION has identified a potential issue in certain manufacturing lots of the Shimadzu Mobile X-ray Systems. Customers are informed that as a result of their investigation, it has been learned that the connecting work of very few column used in specific lots for the MUX series was not done correctly, and it may cause a crack. Therefore, if the machine is continuously used in that condition, there is the possibility that the column will start to lean. The notices i |
| Quantity | 56 units |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001517 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES Shimadzu Corp., Jun 27, 2000 |