Events

Recall of Device Recall Mevatron M2/PRIMUS Plus

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
    38345
  • Event Risk Class
    Class 2
  • Event Number
    Z-0380-2008
  • Event Initiated Date
    2007-03-23
  • Event Date Posted
    2007-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53464
  • 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
    Linear Accelerator - Product Code IYE
  • Reason
    Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
  • Action
    The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.

Device

Device Recall Mevatron M2/PRIMUS Plus
  • Model / Serial
    Model 4504200, Serial Numbers 3672 3675 3695 3727 3728 3751 3773 2931 2941 3002 3042 3068 3158 3191 3212 3244 3257 3273 3276 3382 3406 3407 3418 3424 3443 3489 3492 3504 3515 3516 3547 3564 3578 3579 3583 3587 3592 3597 3638 3641 3663 3666 3667 3825 3835 3919 3949 3994 4004 4036 4061 4232 70-4117 70-4126 70-4133 70-4139 70-4141 70-4185 70-4218 70-4219 70-4279 70-4282 70-4285 70-4308
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, China, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, Ukraine, UK.
  • Product Description
    Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA