Siemens Mobilette Mira, intended use as Mobile x-ray system.
FDA device recall Z-0480-2013 · posted 2012-12-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is a risk of lost images during examination.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 21
- Distribution
- Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.
- Date initiated
- 2012-10-10
- Date posted
- 2012-12-06
- Date terminated
- 2014-01-15
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBILETT MIRA (K111912) | Siemens Medical Solutions USA, Inc. | 2011-09-19 |