Recall Z-2322-2012 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Siemens Mobilett Mira. Mobile X-Ray System.
| Date | Sep 6, 2012 (initiated Aug 21, 2012) |
| Status | Terminated |
| Reason | During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to r |
| Root cause | Device Design |
| Action | Siemens initiated their correction of the MOBILETT Mira on August 21, 2012 by sending an "UPDATE INSTRUCTIONS XP038/12/S to all affected customers. The Instruction identifies the product, problem, and work steps for customers to follow. A XP038/12/S Completion Protocol letter was included for customers to complete and file with the instruction once the update is completed. |
| Quantity | 20 |
| Distribution | Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111912 | MOBILETT MIRA Siemens Medical Solutions USA, Inc., Sep 19, 2011 |