Events

Recall of Ventana Medical System's Symphony Staining System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventana Medical Systems 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
    45437
  • Event Risk Class
    Class 3
  • Event Number
    Z-0300-2008
  • Event Initiated Date
    2007-09-06
  • Event Date Posted
    2008-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65469
  • 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
    in vitro diagnostic - Product Code KEY
  • Reason
    Shock hazard: devices released prior to full testing; the configuration of the symphony instrument during hi pot testing procedures did not completely evaluate all components in the test loop. in specific circumstances, a shock hazard exists.
  • Action
    On 9/6/07, the firm began visiting customers to perform the HiPot test. Prior to performing the High Potential Test of Symphony Instruments already in the Field, the Field Service Engineer or FSE ensures that the customer fully understands the purpose of the test and why it is necessary to perform the test at their site. The FSE conveys the following points regarding the HiPot test: - The HiPot test is a safety verification for the electrical path within the instrument. - The HiPot test was performed incorrectly during the manufacturing process. - The HiPot test is used to verify that if a high voltage overload condition were to occur it would not lead to a short/arc within the instrument, which could pose a risk to anyone that touches the instrument - The HiPot test places a voltage of 2,000VDC onto the high voltage path of the instrument and if any of the insulating components are compromised, the tester will notify the FSE of the condition. - If the instrument fails the HiPot test, the faulty component will be replaced and the instrument will be retested until it passes. - Due to the high voltage used the during the test, no one will be allowed to touch the instrument until the test is complete. The FSE performing the test documents that the customer was informed of the reason for the High Potential Test on their Field Service Report.

Device

Ventana Medical System's Symphony Staining System
  • Model / Serial
    Serial Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and 910060.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Japan and France
  • Product Description
    Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Manufacturer Address
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    USFDA