Z-0480-2013Class II

Siemens Mobilette Mira, intended use as Mobile x-ray system

Name: Z-0480-2013 Siemens Mobilette Mira, intended use as Mobile x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-10-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-10-10 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mobilette Mira, intended use as Mobile x-ray system on 2012-10-10. FDA classified it as Class II and gives the reason as "There is a risk of lost images during examination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0480-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Posted: 2012-12-06
Terminated: 2014-01-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Mobilette Mira, intended use as Mobile x-ray system.
Product code: IZL System, X-Ray, Mobile
Reason for recall: There is a risk of lost images during examination.
Root cause tag: software
FDA 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 in commerce: 21
Distribution: Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.
Product codes and lots: Model Number 10273100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0480-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0480-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-06

Product code IZL

K111912Class IIMobilett MiraSiemens Medical Solutions USA, Inc. / cleared 2011-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)