Recall Z-1875-2013 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Mobiletta Mira Mobile X-ray System
| Date | Aug 5, 2013 (initiated May 2, 2013) |
| Status | Terminated |
| Reason | Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This |
| Root cause | Device Design |
| Action | Siemens sent a Field Safety Notice dated May 2. 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to : 1) Never step or sit on the unit or otherwise put substantial weight on it. 2) Avoid moving the unit over high thresholds for doors or elevators where possible, or do so carefully and slowly. 3) Make sure that no person had his/her extremities under the chassis, also when the unit is not moving. Update instructions were also released to alert customers of the potential risk and to |
| Quantity | 39 |
| Distribution | US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111912 | MOBILETT MIRA Siemens Medical Solutions USA, Inc., Sep 19, 2011 |