Z-2322-2012Class II

Siemens Mobilett Mira. Mobile X-Ray System

Name: Z-2322-2012 Siemens Mobilett Mira. Mobile X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-08-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-08-21 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mobilett Mira. Mobile X-Ray System on 2012-08-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2322-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-21
Posted: 2012-09-06
Terminated: 2014-04-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Mobilett Mira. Mobile X-Ray System.
Product code: IZL System, X-Ray, Mobile
Reason for recall: 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 tag: design
FDA 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 in commerce: 20
Distribution: Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
Product codes and lots: Model number 10273100 -- serial numbers 1034, 1038, 1041, 1042, 1043, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2322-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2322-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

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)