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Siemens Mobilett XP Digital Mobile X-ray System recallZ-1985-2014 · Siemens Medical Solutions USA, Inc · initiated May 9, 2014

Class II Terminated All recalls posted in July 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-1985-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 9, 2014
Posted by the FDA
Jul 2, 2014
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
10
Product code
IZL
FDA submissions
K033238
Distribution
US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

2 devices cleared under K033238 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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