Mobilette Xp and Mobilett Xphybrid

• • Terminated Z-1985-2014 FDA Class II ·initiated 9 May 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 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.

• • Terminated Z-0718-2011 FDA Unclassified (pre-2012) ·initiated 4 Oct 2010

  battery fuse

• • Terminated Z-0171-2011 FDA Unclassified (pre-2012) ·initiated 4 Oct 2010

  Units not equipped with protective plastic cover over electronics.

• • Terminated Z-0749-2007 FDA Unclassified (pre-2012) ·initiated 21 Mar 2007

  Mounting bolts for tank fork assembly and collimator flange may become loose.

510(k) Number

K033238 ↗

FDA Product Code

IZL

Device Class

Class II

Regulation

21 CFR Part 892.1720

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DynaCT

  Class II

  FDA 510(k) K042646 Active Cleared 19 Oct 2004

• Omnia X/Xs Ultrasound System

  Class II

  FDA 510(k) K020353 Active Cleared 13 Feb 2002

• Somatom Project P30L

  Class II

  FDA 510(k) K040577 Active Cleared 22 Mar 2004

• 6 Channel Body Coil

  Class II

  FDA 510(k) K023571 Active Cleared 20 Nov 2002

• Somatom Spirit

  Class II

  FDA 510(k) K042328 Active Cleared 14 Sep 2004

• Somatom P30 CT Systems

  Class II

  FDA 510(k) K013522 Active Cleared 7 Nov 2001

See all devices from Siemens Medical Systems USA, Inc. →