Events

Recall of Device Recall Symbia S Series SPECT System with a Pinhole Collimator

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
    37231
  • Event Risk Class
    Class 2
  • Event Number
    Z-0548-2007
  • Event Initiated Date
    2007-01-30
  • Event Date Posted
    2007-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50151
  • 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
    Single-Photon Emission Computed Tomography - Product Code KPS
  • Reason
    Symbia systems, running on e.Soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
  • Action
    Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.

Device

Device Recall Symbia S Series SPECT System with a Pinhole Collimator
  • Model / Serial
    All systems with pinhole collimators and e.soft software versions 5.5 or earlier: part number 08717741, serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032, 01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.
  • Product Description
    Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA