Recalls / —

—#114043

Product

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

FDA product code

IZL — System, X-Ray, Mobile

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K111912

Affected lot / code info

Model Number 10273100

Why it was recalled

There is a risk of lost images during examination.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

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

Timeline

Recall initiated

2012-10-10

Posted by FDA

2012-12-06

Terminated

2014-01-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #114043. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.