Z-2367-2012Class II

Siemens Mobilett Mira mobile x-ray system

Name: Z-2367-2012 Siemens Mobilett Mira mobile x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-04-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-04-30 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system on 2012-04-30. FDA classified it as Class II and gives the reason as "During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center...". 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-2367-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-30
Posted: 2012-09-11
Terminated: 2012-09-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Product code: IZL System, X-Ray, Mobile
Reason for recall: During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt t
Root cause tag: design
FDA root cause: Device Design
Action: Siemens has issued an Update Instruction XP018/12S in April 2012 to all affected consignees notifying them of the problem. The update instruction provides a correction of the wheel fixation. For questions call Siemens at 610-219-4834 or 610-448-4634.
Quantity in commerce: 9
Distribution: US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
Product codes and lots: Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2367-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2367-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11

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)