Events

Recall of Device Recall Somatom Definition

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
    52435
  • Event Risk Class
    Class 2
  • Event Number
    Z-1675-2009
  • Event Initiated Date
    2009-05-29
  • Event Date Posted
    2009-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82993
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Reason
    Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.
  • Action
    The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems.

Device

Device Recall Somatom Definition
  • Model / Serial
    Serial numbers: 63241, 64009, 64014, 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64079, 64081, 64082, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64112, 64113, 64114, 64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64168, 64169, 64170, 64171, 64172, 64177, 64178, 64179, 64180, 64181, 64189, 64190, 64194, 64199, 64202, 64212, 64214, 64228, 64231, 64232, 64235, 64236, 64239, 64243, 64244, 64245, 64246, 64248, 64253, 64258, 64259, 64260, 64261, 64263, 64270, 64271, 64272, 64273, 64274, 64278, 64282, 64284, 64289, 64290, 64291, 64293, 64296, 64297, 64308, 64310, 64314, 64328, 64337, 64340, 64342, 64347, 64352, and 64354.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, and WY.
  • Product Description
    Somatom Definition Model AS/AS+, Model number 8098027. || Intended use: Computed Tomography X-ray system
  • 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA