Recall Z-1985-2014 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
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.
| Date | Jul 2, 2014 (initiated May 9, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 10 |
| Distribution | US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033238 | MOBILETTE XP AND MOBILETT XPHYBRID Siemens Medical Systems, Inc., Nov 14, 2003 |