Agency classClass IIOur severity:Severe FDA (Devices)·Z-1985-2014·Announced 2014-07-09

Siemens Mobilett XP X-ray System Recalled for Fire Hazard

Siemens is recalling 10 Mobilett XP Digital Mobile X-ray Systems due to a potential fire hazard from Lithium-Ion batteries installed between October 2010 and April 2011.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential fire hazard in a medical device, which meets the rubric criteria for a 'Severe' rating (score 4) due to the risk of significant property damage or injury, even though no specific injuries are reported in the text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 10 units of the Mobilett XP Digital Mobile X-ray System. The recall involves specific Lithium-Ion batteries used in the computers within the systems, either as original manufacturing parts or as spare parts, that were installed between October 2010 and April 2011.

The recall is issued because these specific batteries present a potential fire hazard. The risk of fire may occur at any time, with a higher probability when the system is being charged and connected to the main power supply.

The affected units were distributed in the United States, specifically in the states of Missouri, Georgia, Florida, New Jersey, California, Pennsylvania, and New Mexico. The recalled units are identified by model number 1818447 and specific serial numbers listed in the agency record. Users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the hazard.

The recalled product

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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Mobile X-ray System
Hazard: fire
Affected units: 10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

model no. 1818447
with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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