# K111912: Mobilett Mira

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 19, 2011 after 76 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 66 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033238: Mobilette XP and Mobilett Xphybrid, Siemens Medical Systems, Inc. (2003) Summary page 2.
- K081722: YSIO, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.
- (no number) Mobilett XP hybrid: named in the summary without a submission number

## Most influential descendants
- K193277: SOMATOM On.site and On.scene (2020), 1 descendant of its own
- K241295: SOMATOM On.site (2024), 0 descendants of its own
- K182639: MOBILETT Elara Max (2019), 0 descendants of its own

## Recalls of this device
- Oct 5, 2023 · Class II · Z-0223-2024: Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the a
- May 2, 2013 · Class II · Z-1875-2013: 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 thres
- Oct 10, 2012 · Class II · Z-0480-2013: There is a risk of lost images during examination.
- Aug 21, 2012 · Class II · Z-2322-2012: During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may be
- Apr 30, 2012 · Class II · Z-2367-2012: During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical oper

## Indications for use
The Mobilett Mira is a radiographic system designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

Source page: https://510kreport.com/device/K111912
Methodology: https://510kreport.com/methodology