Recall Z-0480-2013 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Siemens Mobilette Mira, intended use as Mobile x-ray system.
| Date | Dec 6, 2012 (initiated Oct 10, 2012) |
| Status | Terminated |
| Reason | There is a risk of lost images during examination. |
| Root cause | Software design |
| Action | The firm initiated their recall/correction of this product on September 9, 2012 by sending a Field Safety Notification letter with Update Instruction XP054/12/S to all consignees. The letter described the steps to be taken to avoid the potential risk and included a response form to be returned to the recalling firm. |
| Quantity | 21 |
| Distribution | Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, 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 |