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Terminated

Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system

FDA Recall Z-2367-2012 · Posted 2012-09-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2012-04-30
Date Terminated2012-09-25
Product Quantity9

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111912MOBILETT MIRASiemens Medical Solutions USA, Inc. · 2011-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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