FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Mobilette Mira, intended use as Mobile x-ray system.
- Recall number
- Z-0480-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Mobilette Mira, intended use as Mobile x-ray system.
- Status
- Terminated
- Initiated
- 2012-10-10
- Posted
- 2012-12-06
- Terminated
- 2014-01-15
- 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.
- Lot, serial or model codes
- Model Number 10273100
- 510(k) numbers
- ["K111912"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28