Siemens Mobilett Mira. Mobile X-Ray System.
FDA Recall Z-2322-2012 · Posted 2012-09-06
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2012-08-21
Date Terminated2014-04-03
Product Quantity20
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.