Events

Recall of Device Recall Mevatron M2/Primus Mid Energy and PRIMUS HI

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
    76712
  • Event Risk Class
    Class 2
  • Event Number
    Z-1489-2017
  • Event Initiated Date
    2017-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153978
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Software update.
  • Action
    Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.

Device

Device Recall Mevatron M2/Primus Mid Energy and PRIMUS HI
  • Model / Serial
    Device Model# 1940035, 4504200
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed throughout the United States
  • Product Description
    Mevatron M2/Primus Mid-Energy || PRIMUS HI
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA