Events

Recall of SOMATOM Sensation 16

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30173
  • Event Risk Class
    Class 2
  • Event Number
    Z-0158-05
  • Event Date Posted
    2004-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35313
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, X-Ray, Tomography, Computed - Product Code JAK
  • Reason
    Calcium scoring feature on this devices is not closing properly after patient's exams.
  • Action
    The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.

Device

SOMATOM Sensation 16
  • Model / Serial
    Serial Numbers: 50008, 50013, 50014, 50022, 50025, 50026, 50027, 50029, 50034, 50036, 50037, 50040, 50042, 50044, 50048, 50050, 50054, 50058, 50062, 50066, 50073, 50075, 50079, 50081, 50085, 50086, 50089, 50093, 50096, 50097, 50100, 50105, 50106, 50110, 50113, 50123, 50124, 50131, 50134, 50138, 50139, 50141, 50142, 50146, 50152, 50154, 50156, 50158, 50162, 50165, 50166, 50168, 50174, 50175, 50178, 50181, 50183, 50186, 50190, 50192, 50193, 50194, 50202, 50203, 50205, 50212, 50219, 50222, 50224, 50226, 50234, 50238, 50245, 50249, 50250, 50255, 50258, 50262, 50263, 50266, 50273, 50274, 50278, 50283, 50285, 50288, 50293, 50300, 50308, 50310, 50316, 50317, 50325, 50327, 50332, 50334, 50340, 50343, 50351, 50356, 50365, 50374, 50379, 50380, 50391, 50392, 50394, 50394, 50396, 50409, 50412, 50416, 50421, 50429, 50433, 50435, 50452, 50454, 50455, 50458, 50459, 50461, 50462, 50465, 50466, 50467, 50471, 50472, 50473, 50479, 50482, 50483, 50488, 50490, 50491, 50494, 50497, 50501, 50512, 50525, 50530, 50534, 50535, 50540, 50543, 50549, 50550, 50555, 50556, 50557, 50560, 50561, 50564, 50568, 50570, 50573, 50575, 50576, 50577, 50579, 50580, 50582, 50585, 50588, 50590, 50591, 50595, 50597, 50600, 50609, 50610, 50611, 50615, 50621, 50622, 50626, 50627, 50628, 50631, 50632, 50636, 50639, 50640, 50643, 50644, 50545, 50650, 50651, 50653, 50665, 50668, 50669, 50672, 50674, 50682, 50683, 50685, 50686, and 50999.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide and government account in IL.
  • Product Description
    SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model Number 73 93 114
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA