The Recall Desk
ModerateFDA (Devices)·Z-2367-2012·Announced 2012-09-19

Siemens Mobilett Mira Mobile X-Ray System Recalled for Wheel Defect

Siemens is recalling nine Mobilett Mira mobile x-ray systems because a loose center screw on the driving wheel may cause the system to become immobilized.

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 system immobilization without reported injuries or fatalities, fitting the criteria for a moderate severity recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling nine Mobilett Mira mobile x-ray systems. The recall affects model number 10273100 with serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. These units were distributed nationwide in the United States, including in Georgia, Iowa, Kansas, North Carolina, and Texas.

The recall was initiated after the firm identified a potential issue during regular product monitoring. During normal clinical operation, the center screw on the driving wheel may become loose, which can result in the system becoming immobilized. The source text notes that there is no risk of the system tipping over or collapsing on the floor, though the text is truncated regarding the full extent of the tilting risk.

Healthcare facilities and users should stop using the affected units and contact Siemens Medical Solutions USA, Inc. for further instructions on the recall.

The recalled product

Product
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Affected units
9

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 (8)

  • Model number 10273100 - serial numbers 1034
  • 1038
  • 1041
  • 1042
  • 1043
  • 1050
  • 1053
  • and 1054

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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