The Recall Desk
ModerateFDA (Devices)·Z-0480-2013·Announced 2012-12-12

Siemens Mobilette Mira Mobile X-ray System Recalled for Image Loss Risk

Siemens Medical Solutions USA is recalling 21 Mobilette Mira mobile x-ray systems due to a risk of lost images during examination.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (lost images) without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 21 units of the Siemens Mobilette Mira mobile x-ray system. The recall is being conducted because there is a risk of lost images during examination.

The affected units are identified by Model Number 10273100. These devices were distributed nationwide in the United States, including in the states of Georgia, Idaho, Illinois, Iowa, Nebraska, North Carolina, Ohio, South Dakota, Texas, and Wisconsin.

Healthcare facilities and users of these devices should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
Siemens Mobilette Mira, intended use as Mobile x-ray system.
Hazard
Affected units
21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model Number 10273100

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →