Z-1985-2014Class II

Siemens Mobilett XP Digital Mobile X-ray System

Name: Z-1985-2014 Siemens Mobilett XP Digital Mobile X-ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-05-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-05-09 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards... on 2014-05-09. FDA classified it as Class II and gives the reason as "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 Digital mobile...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1985-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-09
Posted: 2014-07-02
Terminated: 2014-12-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid 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.
Product code: IZL System, X-Ray, Mobile
Reason for recall: 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 Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens sent a Safety Advisory Notice letter dated May 9, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that a Siemens service technician would be visiting their site to identify and service affected devices.
Quantity in commerce: 10
Distribution: US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.
Product codes and lots: model no. 1818447, with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1985-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1985-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02

Product code IZL

K033238Class IIMobilette Xp and Mobilett XphybridSiemens Medical Systems, Inc. / cleared 2003-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)