Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This |
| Product | Mobiletta Mira Mobile X-ray System |
| Quantity | 39 |
| Distribution | US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL. |
| Initiated | 2013-05-02 |
| Classified | 2013-08-05 |
| Terminated | 2015-02-24 |
| Recall number | Z-1875-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-1875-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65605/
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