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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Mobile X-Ray
- 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
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