Events

Recall of Device Recall Siemens

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
    67780
  • Event Risk Class
    Class 2
  • Event Number
    Z-1460-2014
  • Event Initiated Date
    2014-03-05
  • Event Date Posted
    2014-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126309
  • 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
    Table, radiographic, non-tilting, powered - Product Code IZZ
  • Reason
    There is a potential issue and possible hazard to patients when using the axiom vertix md trauma systems. in rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the u-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.
  • Action
    Siemens sent a Safety Advisory Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised as a first check it is strongly recommended for the users to check whether metallic dust or rubbed off parts of metal are visible underneath the lifting column or around the system. If this is the case, it is strongly recommended to immediately stop using the Vertix MD Trauma system and call the local Siemens service. To avoid any risk until the implementation of the modification mentioned below, it is furthermore strongly recommended to perform up/down movements of the lifting column not directly above the patient, but complete the vertical movement beside the patient and then move the system horizontally above the patient. We appreciate your understanding and cooperation with this Safety Advisory Notice and ask you to immediately instruct your personnel accordingly. Please ensure that this Safety Advisory Notice is placed in the system's instructions for use until the update has been installed. If you have sold or otherwise disposed of this equipment and it is no under your control, we kindly ask that you forward this Safety Advisory Notice to the new user of the equipment. Please also inform us about the new owner of the equipment. We apologize for any inconvenience this may cause. Further questions please call (610) 219-6300.

Device

Device Recall Siemens
  • Model / Serial
    AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including MO and OH.
  • Product Description
    AXIOM Vertix MD Trauma systems || radiographic X-ray
  • 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