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Terminated

Siemens Mobilette Mira, intended use as Mobile x-ray system.

FDA Recall Z-0480-2013 · Posted 2012-12-06

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2012-10-10
Date Terminated2014-01-15
Product Quantity21

Reason for Recall

There is a risk of lost images during examination.

Firm Action

The firm initiated their recall/correction of this product on September 9, 2012 by sending a Field Safety Notification letter with Update Instruction XP054/12/S to all consignees. The letter described the steps to be taken to avoid the potential risk and included a response form to be returned to the recalling firm.

Root Cause

Software design

Distribution Pattern

Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.

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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