—#127494

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.

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033238
Affected lot / code info: model no. 1818447, with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.

Timeline

Recall initiated: 2014-05-09
Posted by FDA: 2014-07-02
Terminated: 2014-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127494. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.