Severity
Moderate
FDA Devices recall · Reported September 12, 2012
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 han…
Siemens Medical Solutions USA, Inc recalled Siemens Mobilett Mira. Mobile X-Ray System. - a moderate-severity action.
Siemens Mobilett Mira. Mobile X-Ray System. was recalled by Siemens Medical Solutions USA, Inc in September 12, 2012. Reason: During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira syste…. Check the official notice for the remedy. Verify recall #Z-2322-2012 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira syste….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2322-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2322-2012) was formally reported on September 12, 2012, with the manufacturer initiating the action on August 21, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records list the affected scope as 20.
The documented reason for this recall is: 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 sli… Distribution data in the federal record shows the product reached: Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
20
Related Recalls
6
3 from same agency
Siemens Mobilett Mira. Mobile X-Ray System.
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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2322-2012 |
| Date reported | September 12, 2012 |
| Date initiated | August 21, 2012 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 20 |
| Distribution | Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 12, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.