Events

Recall of Device Recall PRIMEVIEW 3i System

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
    48439
  • Event Risk Class
    Class 2
  • Event Number
    Z-2097-2008
  • Event Initiated Date
    2008-05-15
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71417
  • 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 - under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
  • Action
    An Urgent Medical Device Correction - Customer Safety Advisory Notice letter (TH014/08/S) was released on May 15, 2008. A new software patch is under construction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925) 246-8407.

Device

Device Recall PRIMEVIEW 3i System
  • Model / Serial
    Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1  Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Product distribution information pending from firm.
  • Product Description
    Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
  • 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