# K033238: Mobilette XP and Mobilett Xphybrid

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Nov 14, 2003 after 39 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932106 (1994). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932106: Mobilett Plus Mobile X-Ray System, Siemens Medical Solutions USA, Inc. (1994) Summary page 1.

## Most influential descendants
- K111912: Mobilett Mira (2011), 3 descendants of its own
- 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
- May 9, 2014 · Class II · Z-1985-2014: There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP 
- Oct 4, 2010 · Not classified · Z-0171-2011: Units not equipped with protective plastic cover over electronics.
- Oct 4, 2010 · Not classified · Z-0718-2011: battery fuse
- Mar 21, 2007 · Not classified · Z-0749-2007: Mounting bolts for tank fork assembly and collimator flange may become loose.

## Indications for use
The Mobilett XP and Mobilett XPhybrid are radiographic systems 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/K033238
Methodology: https://510kreport.com/methodology