CLASS II Device recall · Reported 12 Dec 2012 · FDA Enforcement Report

Siemens Mobilette Mira recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Siemens Mobilette Mira, distributed nationwide in the US. The recall was initiated on 10 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number 10273100

Quantity recalled21

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0480-2013
FDA event ID: 63495
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2012
FDA classified: 6 Dec 2012
Reported: 12 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

10 Oct 2012	Recall initiated by company
6 Dec 2012	Classified by FDA	+57 days
12 Dec 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a risk of lost images during examination.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Georgia Iowa Idaho Illinois North Carolina Nebraska Ohio South Dakota Texas Wisconsin

Questions about this recall

Is Siemens Mobilette Mira recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Mobilette Mira on 10 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0480-2013.

Why was it recalled?

There is a risk of lost images during examination.

Which lots are affected?

Model Number 10273100

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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