Events

Recall of Device Recall Oncor Impression 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-0381-2008
  • 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=66447
  • 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 Oncor Impression Plus
  • Model / Serial
    Model number 5857912, Serial Numbers 3739 3753 3761 3764 3769 3776 3783 3791 3793 3796 3799 3801 3802 3808 3827 3841 3846 3848 3858 3865 3877 3901 3945 3948 3953 3954 3955 3957 3964 3965 3975 3981 3983 3989 3998 4002 4005 4008 4009 4011 4015 4017 4019 4022 4027 4035 4053 4065 4067 4068 4072 4074 4084 4091 4096 5004 70-4097 70-4107 70-4119 70-4122 70-4123 70-4124 70-4127 70-4129 70-4132 70-4135 70-4136 70-4137 70-4142 70-4144 70-4145 70-4147 70-4149 70-4153 70-4154 70-4157 70-4158 70-4159 70-4161 70-4166 70-4171 70-4172 70-4174 70-4175 70-4176 70-4177 70-4183 70-4209 70-4215 70-4222 70-4224 70-4231 70-4241 70-4244 70-4253 70-4258 70-4262 70-4272 70-4278 70-4288 70-4295 70-4299 70-4301 70-4305 70-4306 70-4312 70-4317 70-4328 70-4329 70-4334 70-4335 70-4343 70-4345 70-4346 70-4348 70-4349 70-4356
  • 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, Oncor Impression Plus, Part No.: 58 57 912, Medical 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