Siemens Recalls Mobiletta Mira Mobile X-ray Systems Due to Wheel Shaft Risk
Siemens is recalling 39 Mobiletta Mira mobile X-ray systems because a main wheel shaft could break from material fatigue, causing the chassis to fall.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (wheel shaft breakage) that could cause the heavy chassis to fall, posing a significant injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 39 units of the Mobiletta Mira Mobile X-ray System (Model number 10273100). The recall was initiated after Siemens issued a Field Safety Alert regarding a potential risk to users when operating the device.
The hazard involves the potential for one of the system's main wheel shafts to break due to material fatigue. This breakage can occur if the device is regularly exposed to extensive mechanical strain, such as being driven over high thresholds for doors or elevators. If a shaft breaks, the chassis may fall to the ground on the affected wheel side.
The affected units were distributed across the United States, including the states of Iowa, South Dakota, North Carolina, Wisconsin, Ohio, Nebraska, Texas, Kansas, Idaho, Michigan, Georgia, Arkansas, and Illinois. Users should stop using the affected equipment and contact Siemens Medical Solutions USA, Inc. for instructions on the recall.
The recalled product
- Product
- Mobiletta Mira Mobile X-ray System
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 39
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
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